System and method for wireless communication of analyte data

ABSTRACT

Systems, methods, apparatuses, and devices, for the wireless communication of analyte data are provided. In some embodiments, a method and calibration station for calibrating a continuous analyte sensor system is provided. Methods and testing systems for testing a continuous analyte sensor system is provided. Continuous analyte sensor systems, display devices and peripheral devices configured for wireless communication of analyte, connection, alarm and/or alert data and associated methods are provided.

INCORPORATION BY REFERENCE TO RELATED APPLICATIONS

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application cis a continuation of U.S. application Ser.No. 16/881,592, filed May 22, 2020, which claims the benefit of U.S.Provisional Application No. 62/853,957, filed May 29, 2019. Theaforementioned application is incorporated by reference herein in itsentirety, and is hereby expressly made a part of this specification.

TECHNICAL FIELD

The present disclosure relates generally to continuous monitoring ofanalyte values received from an analyte sensor system. Moreparticularly, the present disclosure is directed to systems, methods,apparatuses, and devices, for the wireless communication of analytedata.

BACKGROUND

Diabetes mellitus is a disorder in which the pancreas cannot createsufficient insulin (Type I or insulin dependent) and/or in which insulinis not effective (Type 2 or non-insulin dependent). In the diabeticstate, the victim suffers from high blood sugar, which causes an arrayof physiological derangements (kidney failure, skin ulcers, or bleedinginto the vitreous of the eye) associated with the deterioration of smallblood vessels. A hypoglycemic reaction (low blood sugar) can be inducedby an inadvertent overdose of insulin, or after a normal dose of insulinor glucose-lowering agent accompanied by extraordinary exercise orinsufficient food intake.

Conventionally, a diabetic person carries a self-monitoring bloodglucose (SMBG) monitor, which typically requires uncomfortable fingerpricking methods. Due to the lack of comfort and convenience, a diabeticwill normally only measure his or her glucose level two to four timesper day. Unfortunately, these time intervals are spread so far apartthat the diabetic will likely be alerted to a hyperglycemic orhypoglycemic condition too late, sometimes incurring dangerous sideeffects as a result. In fact, it is not only unlikely that a diabeticwill take a timely SMBG value but will not know if his blood glucosevalue is going up (higher) or down (lower), due to limitations ofconventional methods.

Consequently, a variety of non-invasive, transdermal (e.g.,transcutaneous) and/or implantable electrochemical sensors are beingdeveloped for continuously detecting and/or quantifying blood glucosevalues. These devices generally transmit raw or minimally processed datafor subsequent analysis at a remote device, which can include a display.The transmission to wireless display devices can be wireless.

With respect to the wireless transmission of glucose and other analytedata gathered using an implanted sensor, battery life of the transmitteracting in conjunction with the sensor is typically a concern. Toconserve battery life or to increase the efficiency associated with thetransmission of glucose and other analyte data, transmissions can, forexample, need to be intermittent. The intermittent transmission ofmonitored data can introduce reliability issues, however. In some cases,reliability is thus sacrificed for battery life in conventional sensorsystems.

SUMMARY

A method for calibrating a continuous analyte sensor system is provided.The method includes scanning an identification tag encoding informationidentifying the analyte sensor system. The method includes retrievingcalibration data for a sensor of the analyte sensor system based atleast in part on the information identifying the analyte sensor system.The method includes disposing the analyte sensor system sufficientlyclose to a calibration station for a short-range communicationcontroller of the calibration station to induce a short-range antenna ofthe analyte sensor system to cause at least a portion of the analytesensor system to transition to an operational mode. The method includestransferring at least the sensor calibration data from the calibrationstation to the continuous analyte sensor system via short-rangecommunications responsive to a command, thereby facilitating calibrationof the continuous analyte sensor system.

In some embodiments, the method includes causing the analyte sensorsystem to revert to a sleep mode after the sensor calibration data isstored in a storage of the analyte sensor system. In some embodiments,the identification tag is a 2-dimensional (2D) barcode encoding at leasta lot number of an applicator and a serial number of the sensor of theanalyte sensor system in a single string. In some embodiments, thesensor calibration data comprises an initial slope determined for thesensor, a final slope determined for the sensor, and an indication of adate on which the initial slope and the final slope was determined. Insome embodiments, the command comprises an 0x7a near-field communicationcommand configured to transmit each of a lot number of an applicator, aserial number of the sensor, the initial slope, the final slope and theindication of the date in a single message. In some embodiments, thesensor calibration data is retrieved form a database in which the sensorcalibration data is indexed according to the lot number of theapplicator and the serial number of the sensor.

A calibration station configured for calibrating a continuous analytesensor system is provided. The calibration station includes anidentification tag scanner configured to scan an identification tagencoding information identifying the analyte sensor system. Thecalibration station includes a processor configured to retrievecalibration data for a sensor of the analyte sensor system based atleast in part on the information identifying the analyte sensor system.The calibration station includes a short-range communication controllerconfigured to induce a short-range antenna of the analyte sensor systemto cause at least a portion of the analyte sensor system to transitionto an operational mode when the analyte sensor system is disposedsufficiently close to the calibration station, and transfer at least thesensor calibration data to the analyte sensor system via short-rangecommunications responsive to a command, thereby facilitating calibrationof the analyte sensor system.

In some embodiments, the short-range communication controller is furtherconfigured to send at least one signal to the analyte sensor system thatcauses the analyte sensor system to revert to a sleep mode after thesensor calibration data is stored in a storage of the analyte sensorsystem. In some embodiments, the identification tag is a 2-dimensional(2D) barcode encoding at least a lot number of an applicator and aserial number of the sensor of the analyte sensor system in a singlestring. In some embodiments, the sensor calibration data comprises aninitial slope determined for the sensor, a final slope determined forthe sensor, and an indication of a date on which the initial slope andthe final slope was determined. In some embodiments, the commandcomprises an 0x7a NFC command configured to transmit each of a lotnumber of an applicator, a serial number of the sensor, the initialslope, the final slope and the indication of the date in a singlemessage. In some embodiments, the sensor calibration data is retrievedfrom a database in which the sensor calibration data is indexedaccording to the lot number of the applicator and the serial number ofthe sensor.

A method for testing a continuous analyte sensor system is provided. Themethod includes waking at least a portion of an analyte sensor systemfrom a sleep mode. The method include receiving, utilizing a firsttransceiver chip, a data packet transmitted from a second transceiverchip, the data packet comprising a request for the analyte sensor systemto perform one or more tasks designed to verify anticipated operation ofthe analyte sensor system. The method includes processing the request.The method includes transmitting, utilizing the first transceiver chip,a response returning a result of the request to the second transceiverchip. The method includes receiving, utilizing the first transceiverchip, a message transmitted from the second transceiver chip, themessage comprising instructions that cause one or more components of theanalyte sensor system to revert to a sleep mode.

In some embodiments, the first transceiver chip is embedded in theanalyte sensor system and the second transceiver chip is embedded in afactory testing station configured to test operation of the analytesensor system. In some embodiments, each of the request, the response,and the message are communicated on a frequency channel that ispre-programmed into each of the first transceiver chip and the secondtransceiver chip. In some embodiments, the request, the response and themessage are communicated without any prior connection or authenticationprocesses occurring between the first transceiver chip and the secondtransceiver chip.

A method for testing a continuous analyte sensor system is provided. Themethod includes transmitting to a first transceiver chip, utilizing asecond transceiver chip, a data packet comprising a request for theanalyte sensor system to perform one or more tasks designed to verifyanticipated operation of the analyte sensor system. The method includesreceiving, utilizing the second transceiver chip, a response returning aresult of the request from the first transceiver chip. The methodincludes transmitting, utilizing the second transceiver chip, a messageto the first transceiver chip, the message comprising instructions thatcause one or more components of the analyte sensor system to revert to asleep mode.

In some embodiments, the first transceiver chip is embedded in theanalyte sensor system and the second transceiver chip is embedded in afactory testing station configured to test operation of the analytesensor system. In some embodiments, each of the request, the response,and the message are communicated on a frequency channel that ispre-programmed into each of the first transceiver chip and the secondtransceiver chip. In some embodiments, the request, the response and themessage are communicated without any prior connection or authenticationprocesses occurring between the first transceiver chip and the secondtransceiver chip.

A testing system for testing a continuous analyte sensor system isprovided. The testing system includes the analyte sensor systemcomprising a first transceiver chip. The testing system includes afactory testing station comprising a second transceiver chip. Theanalyte sensor system is configured to wake at least a portion of theanalyte sensor system from a sleep mode. The analyte sensor system isconfigured to receive, utilizing the first transceiver chip, a datapacket transmitted from the second transceiver chip, the data packetcomprising a request for the analyte sensor system to perform one ormore tasks designed to verify anticipated operation of the analytesensor system. The analyte sensor system is configured to process therequest. The analyte sensor system is configured to transmit, utilizingthe first transceiver chip, a response returning a result of the requestto the second transceiver chip. The analyte sensor system is configuredto receive, utilizing the first transceiver chip, a message transmittedfrom the second transceiver chip, the message comprising instructionsthat cause one or more components of the analyte sensor system to revertto a sleep mode. The factory testing station is configured to transmitthe data packet to the first transceiver chip utilizing the secondtransceiver chip. The factory testing station is configured to receivethe response from the first transceiver chip utilizing the secondtransceiver chip. The factory testing station is configured to transmitthe message to the first transceiver chip utilizing the secondtransceiver chip.

In some embodiments, each of the first transceiver chip and the secondtransceiver chip are pre-programmed to communicate each of the request,the response, and the message on a pre-determined frequency channel. Insome embodiments, the first transceiver chip and the second transceiverchip communicate the request, the response and the message without anyprior connection or authentication processes.

A continuous analyte sensor system configured for wireless communicationof analyte data is provided. The system includes a sensor comprising aplurality of terminals, the sensor configured to generate a currentthrough the plurality of terminals based on an analyte concentration ofa host. The system includes a shorting element configured toelectrically short the plurality of terminals when the sensor isdisposed in a packaging. The system includes a sensor electronics moduleconfigured to wake periodically, measure the current through theplurality of terminals, determine that the measured current is below apredetermined threshold; and generate a signal configured to wake atleast one additional component of the analyte sensor system based on thedetermination.

In some embodiments, the shorting element comprises at least one of anelectrically conductive wire, an electrically conductive sheet, or anelectrically conductive foam comprising at least a portion of thepackaging.

A method for wireless communication of continuous analyte data isprovided. The method includes generating a pairing key. The methodincludes initializing a transceiver radio with a first peripheralinstance and a second peripheral instance. The method includesgenerating and transmitting a first advertisement message associatedwith the first peripheral instance. The method includes generating andtransmitting a second advertisement message associated with the secondperipheral instance and comprising the pairing key. The method includesdetermining that a pairing request corresponding to the first peripheralinstance has been received. The method includes determining that thepairing request comprises the pairing key. The method includesgenerating and transmitting a pairing request acceptance message basedon the pairing request comprising the pairing key.

In some embodiments, the method includes encrypting the pairing key,wherein the second advertisement message comprises the encrypted pairingkey and the pairing request comprises a decrypted version of theencrypted pairing key. In some embodiments, the first advertisementmessage comprises one or more of an indication of a manufacturer of ananalyte sensor system, an address identifying the analyte sensor system,an indication that the first peripheral instance is connectable, and anindication of out-of-band authentication. In some embodiments, thesecond advertisement message comprises one or more of an indication ofthe manufacturer of the analyte sensor system, the address identifyingthe analyte sensor system, an indication that the second peripheralinstance is not connectable, and a payload comprising the pairing key.In some embodiments, the first peripheral instance and the secondperipheral instance are both associated with a same analyte sensorsystem. In some embodiments, the first advertisement message and thesecond advertisement message are transmitted during a same pairingsession.

A continuous analyte sensor system is provided. The system includes ananalyte sensor. The system includes a transceiver radio. The systemincludes one or more processors configured to generate a pairing key.The one or more processors are configured to initialize the transceiverradio with a first peripheral instance and a second peripheral instance.The one or more processors are configured to generate and transmit, viathe transceiver radio, a first advertisement message associated with thefirst peripheral instance. The one or more processors are configured togenerate and transmit, via the transceiver radio, a second advertisementmessage associated with the second peripheral instance and comprisingthe pairing key. The one or more processors are configured to determinethat a pairing request corresponding to the first peripheral instancehas been received via the transceiver radio. The one or more processorsare configured to determine that the pairing request comprises thepairing key. The one or more processors are configured to generate andtransmit, via the transceiver radio, a pairing request acceptancemessage based on the pairing request comprising the pairing key.

A method for wireless communication of continuous analyte data isprovided. The method includes monitoring one or more communicationchannels for one or more advertising messages indicative of an analytesensor system initiating a pairing operation with a peripheral device.The method includes determining that a first advertisement message hasbeen received from the analyte sensor system, the first advertisementmessage comprising an indication of a predetermined manufacturer of theanalyte sensor system and an address identifying the analyte sensorsystem. The method includes determining that a second advertisementmessage comprising the indication of the predetermined manufacturer, theaddress identifying the analyte sensor system, and a pairing key hasbeen received from the analyte sensor system. The method includesextracting the pairing key from the second advertisement message. Themethod includes generating and transmitting a pairing request messagecomprising the extracted pairing key. The method includes receiving apairing request acceptance message based on the pairing request message.

In some embodiments, the pairing key within the second advertisementmessage is encrypted and the pairing request comprises a decryptedversion of the encrypted pairing key, the method including decryptingthe pairing key to obtain the decrypted version of the encrypted pairingkey. In some embodiments, the first advertisement message furthercomprises one or more of an indication that a first peripheral instanceof the analyte sensor system is connectable, and an indication ofout-of-band authentication. In some embodiments, the secondadvertisement message further comprises an indication that a secondperipheral instance of the analyte sensor system is not connectable, thepairing key being disposed in a payload of the second advertisementmessage. In some embodiments, the first advertisement message and thesecond advertisement message are received during a same pairing session.

A peripheral device is provided. The device includes a display, atransceiver radio, and one or more processors configured to monitor oneor more communication channels for one or more advertising messagesindicative of an analyte sensor system initiating a pairing operationwith the peripheral device. The one or more processors are configured todetermine that a first advertisement message has been received from theanalyte sensor system, the first advertisement message comprising anindication of a predetermined manufacturer of the analyte sensor systemand an address identifying the analyte sensor system. The one or moreprocessors are configured to determine that a second advertisementmessage comprising the indication of the predetermined manufacturer, theaddress identifying the analyte sensor system, and a pairing key hasbeen received from the analyte sensor system. The one or more processorsare configured to extract the pairing key from the second advertisementmessage. The one or more processors are configured to generate andtransmit, via the transceiver radio, a pairing request messagecomprising the extracted pairing key. The one or more processors areconfigured to receive, via the transceiver radio, a pairing requestacceptance message based on the pairing request message.

A method for wireless communication of continuous analyte data isprovided. The method includes transmitting an advertisement message forestablishing a communication channel. The method includes receiving arandom number encrypted utilizing a first public key over thecommunication channel. The method includes decrypting the encryptedrandom number utilizing a first private key associated with the firstpublic key. The method includes re-encrypting the decrypted randomnumber utilizing a second public key. The method includes transmittingthe re-encrypted random number over the communication channel. Themethod includes transmitting sensor data encrypted utilizing the secondpublic key.

In some embodiments, the first private key is one of a first pluralityof unique private keys configured to decrypt data previously encryptedutilizing the first public key and the second private key is one of asecond plurality of unique private keys configured to decrypt datapreviously encrypted utilizing the second public key. In someembodiments, the first public key and the second public key are publiclyavailable keys, and the first private key and the second private key arenot publicly available keys. In some embodiments, the method includesreceiving at least one of the first private key and the second publickey from a server.

A continuous analyte sensor system is provided. The system includes ananalyte sensor, a transceiver radio, and one or more processorsconfigured to cause an advertisement message for establishing acommunication channel to be transmitted. The one or more processors areconfigured to receive a random number encrypted utilizing a first publickey over the communication channel. The one or more processors areconfigured to decrypt the encrypted random number utilizing a firstprivate key associated with the first public key. The one or moreprocessors are configured to re-encrypt the random number utilizing asecond public key. The one or more processors are configured to causethe re-encrypted random number to be transmitted over the communicationchannel. The one or more processors are configured to cause sensor dataencrypted utilizing the second public key to be transmitted.

A method for wireless communication of continuous analyte data isprovided. The method includes receiving an advertisement message forestablishing a communication channel. The method includes generating arandom number. The method includes encrypting the random numberutilizing a first public key. The method includes transmitting theencrypted random number utilizing the communication channel. The methodincludes receiving the random number re-encrypted utilizing a secondpublic key. The method includes decrypting the re-encrypted randomnumber utilizing a second private key. The method includes comparing thedecrypted random number to the random number originally generated. Themethod includes authenticating a communication session based on adetermination that the decrypted random number and the random numberoriginally generated are the same. The method includes receiving sensordata encrypted utilizing the second public key.

In some embodiments, the first private key is one of a first pluralityof unique private keys configured to decrypt data previously encryptedutilizing the first public key and the second private key is one of asecond plurality of unique private keys configured to decrypt datapreviously encrypted utilizing the second public key. In someembodiments, the first public key and the second public key are publiclyavailable keys, and the first private key and the second private key arenot publicly available keys.

A peripheral device is provided. The device includes a display, atransceiver radio; and one or more processors configured to receive anadvertisement message for establishing a communication channel. The oneor more processors are configured to generate a random number. The oneor more processors are configured to encrypt the random number utilizinga first public key. The one or more processors are configured totransmit the encrypted random number utilizing the communicationchannel. The one or more processors are configured to receive the randomnumber re-encrypted utilizing a second public key. The one or moreprocessors are configured to decrypt the re-encrypted random numberutilizing a second private key. The one or more processors areconfigured to compare the decrypted random number to the random numberoriginally generated. The one or more processors are configured toauthenticate a communication session based on a determination that thedecrypted random number and the random number originally generated arethe same. The one or more processors are configured to receive sensordata encrypted utilizing the second public key.

A method for wireless communication of continuous analyte data isprovided. The method includes successively coupling each of a pluralityof filtering circuits to an antenna, each of the filtering circuitsconfigured to pass a respective signal received by the antenna in arespective frequency channel. The method includes measuring a respectiveamount of power received on each respective frequency channel while theanalyte sensor system is not wirelessly communicating. The methodincludes comparing the measured respective amounts of power received oneach respective frequency channel. The method includes selecting therespective frequency channel having the lowest measured amount of powerfor the antenna to transmit one or more signals.

In some embodiments, each of the plurality of filtering circuitscomprises a bandpass filter. In some embodiments, successively couplingeach of the plurality of filtering circuits to the antenna comprisessuccessively closing a respective switch coupling a respective one ofthe filtering circuits to the antenna. In some embodiments, selectingthe respective frequency channel having the lowest measured amount ofpower for the antenna to transmit one or more signals comprises sendingat least one signal causing a frequency selection circuit of atransmitter to select the respective frequency channel.

A continuous analyte sensor system is provided. The system includes anantenna and a plurality of filtering circuits couplable to the antenna,each of the filtering circuits configured to pass a respective signalreceived by the antenna in a respective frequency channel. The systemincludes one or more processors configured to successively couple eachof the plurality of filtering circuits to the antenna. The one or moreprocessors are configured to measure a respective amount of powerreceived on each respective frequency channel while the analyte sensorsystem is not wirelessly communicating. The one or more processors areconfigured to compare the measured respective amounts of power receivedon each respective frequency channel. The one or more processors areconfigured to select the respective frequency channel having the lowestmeasured amount of power for the antenna to transmit one or moresignals.

A method for wireless communication of analyte data by a continuousanalyte sensor system is provided. The method includes preconfiguringthe analyte sensor system to periodically wake from a low-power passivemonitoring mode according to a predetermined interval for waking theanalyte sensor system. The method includes receiving a wake signal froma display device before expiration of the predetermined interval whilethe analyte sensor system is in the low-power passive monitoring mode,thereby causing the analyte sensor system to wake before expiration ofthe predetermined interval. The method includes transmitting anadvertisement message in response to the wake signal. The methodincludes receiving a pairing request from the display device. The methodincludes transmitting a pairing request acceptance message to thedisplay device. The method includes transmitting sensor data to thedisplay device.

In some embodiments, the transmitting sensor data to the display deviceoccurs at a time before the predetermined interval for waking theanalyte sensor system has expired. In some embodiments, the wake signalhas a predetermined pattern, magnitude or modulation configured to causethe analyte sensor system to wake from the low-power passive monitoringmode.

A continuous analyte sensor system is provided. The system includes ananalyte sensor and a transceiver radio. The system includes one or moreprocessors configured to preconfigure the analyte sensor system toperiodically wake from a low-power passive monitoring mode according toa predetermined interval for waking the analyte sensor system. The oneor more processors are configured to receive a wake signal from adisplay device before expiration of the predetermined interval while theanalyte sensor system is in a low-power passive monitoring mode, therebycausing the analyte sensor system to wake before expiration of thepredetermined interval. The one or more processors are configured tocause an advertisement message to be transmitted in response to the wakesignal. The one or more processors are configured to receive a pairingrequest from the display device. The one or more processors areconfigured to cause a pairing request acceptance message to betransmitted to the display device and cause transmission of sensor datato the display device.

A method for wireless communication of continuous analyte data by adisplay device is provided. The method includes transmitting a wakesignal to an analyte sensor system that is in a low-power passivemonitoring mode. The method includes receiving an advertisement messageresponsive to the wake signal. The method includes transmitting apairing request to the analyte sensor system. The method includesreceiving a pairing request acceptance message responsive to the pairingrequest. The method includes receiving sensor data from the analytesensor system.

In some embodiments, the receiving sensor data from the analyte sensorsystem occurs at a time before a predetermined interval for waking theanalyte sensor system has expired. In some embodiments, the wake signalhas a predetermined pattern, magnitude or modulation configured to causethe analyte sensor system to wake from the low-power passive monitoringmode.

A display device is provided. The device includes a display and atransceiver radio. The device includes one or more processors configuredto cause a wake signal to be transmitted to an analyte sensor systemthat is in a low-power passive monitoring mode. The one or moreprocessors are configured to receiving an advertisement messageresponsive to the wake signal. The one or more processors are configuredto causing a pairing request to be transmitted to the analyte sensorsystem. The one or more processors are configured to receiving a pairingrequest acceptance message responsive to the pairing request. The one ormore processors are configured to receiving sensor data from the analytesensor system.

A method for wireless communication of continuous analyte data isprovided. The method includes physically moving a short-range wirelesscommunication protocol-enabled display device sufficiently close to asticker physically disposed on one of an analyte sensor system or apackaging for the analyte sensor system, comprising a short-rangewireless communications tag having pre-programmed thereon a pairing key,such that the display device is able to retrieve the pairing key fromthe tag via the short-range wireless communication protocol. The methodincludes pairing the display device with the analyte sensor system for awireless protocol different from the short-range wireless communicationprotocol utilizing the retrieved pairing key.

In some embodiments, the pairing key is associated with the analytesensor system. In some embodiments, the physically moving theNFC-enabled display device sufficiently close to the sticker comprisestapping the display device on the sticker.

A display device is provided. The device includes a display, ashort-range wireless communication protocol-enabled radio and a radioenabled for wireless communication utilizing a wireless protocoldifferent from the short-range wireless communication protocol. Thedevice includes one or more processors configured to retrieve, utilizingthe short-range wireless communication protocol-enabled radio, a pairingkey from a short-range wireless communications tag embedded in a stickerbased on the display device being physically moved sufficiently close tothe sticker, the tag being pre-programmed with the pairing key and thepairing key being associated with an analyte sensor system. The one ormore processors are configured to perform a pairing operation with theanalyte sensor system for the wireless communication protocol differentfrom the short-range wireless communication protocol utilizing theretrieved pairing key.

In some embodiments, the display device being physically movedsufficiently close to the sticker comprises tapping the display deviceon the sticker.

A method for wireless communication of continuous analyte data isprovided. The method includes detecting an advertisement message from ananalyte sensor system. The method includes attempting to establish aconnection with the analyte sensor system responsive to theadvertisement message. The method includes determining that the attemptto establish the connection with the analyte sensor system has failed.The method includes generating an alert indicating that the analytesensor system has been detected but an attempt to establish theconnection with the analyte sensor system has failed.

In some embodiments, the alert comprises at least one suggested userintervention for improving the probability of establishing theconnection with the analyte sensor system on a subsequent connectionattempt.

A display device is provided. The device includes a display and atransceiver radio. The device includes one or more processors configuredto detect an advertisement message from an analyte sensor system. Theone or more processors are configured to attempt to establish aconnection with the analyte sensor system responsive to theadvertisement message. The one or more processors are configured todetermine that the attempt to establish the connection with the analytesensor system has failed. The one or more processors are configured togenerate an alert indicating that the analyte sensor system has beendetected but an attempt to establish the connection with the analytesensor system has failed.

A method for wireless communication of continuous analyte data isprovided. The method includes transmitting a wake signal to an analytesensor system. The method includes receiving a transmitter IDcorresponding to the analyte sensor system. The method includescomparing the received transmitter ID to a range of transmitter IDscorresponding to currently deployed analyte sensor systems. The methodincludes establishing a wireless connection with the analyte sensorsystem based on a determination that the received transmitter ID iswithin the range of transmitter IDs corresponding to analyte sensorsystems currently deployed. The method includes receiving at leastlogged analyte concentration data from the analyte sensor system. Themethod includes generating one or more reports based on at least thelogged analyte concentration data from the analyte sensor system.

In some embodiments, the wake signal is transmitted utilizing anelectromagnet.

A device is provided, including a transceiver radio and anelectromagnet. The device includes one or more processors configured tocause the electromagnet to transmit a wake signal to an analyte sensorsystem. The one or more processors are configured to receive atransmitter ID corresponding to the analyte sensor system. The one ormore processors are configured to compare the received transmitter ID toa range of transmitter IDs corresponding to currently deployed analytesensor systems. The one or more processors are configured to establish awireless connection with the analyte sensor system based on adetermination that the received transmitter ID is within the range oftransmitter IDs corresponding to currently deployed analyte sensorsystems. The one or more processors are configured to receive at leastanalyte concentration data logged by the analyte sensor system during aprior sensor session. The one or more processors are configured togenerate one or more reports based on at least the logged analyteconcentration data.

A method for wireless communication of continuous analyte data isprovided. The method includes receiving a wake signal from a heath careprovider device. The method includes transmitting a transmitter IDcorresponding to an analyte sensor system. The method includesestablishing a wireless connection with the health care provider devicebased on the transmitted transmitter ID being within a range oftransmitter IDs corresponding to currently deployed analyte sensorsystems. The method includes transmitting at least logged analyteconcentration data to the health care provider device.

In some embodiments, the method includes generating analyteconcentration data during a sensor session. In some embodiments, themethod includes logging the analyte concentration data during the sensorsession. In some embodiments, the wake signal is received by a magneticsensor at a time after the sensor session has concluded.

A continuous analyte sensor system is provided. The system includes ananalyte sensor configured to generate analyte concentration data duringa sensor session. The system includes a storage configured to log theanalyte concentration data during the sensor session. The systemincludes a magnetic sensor configured to receive a wake signal from aheath care provider device. The system includes a transceiver radio. Thesystem includes one or more processors configured to cause thetransceiver radio to transmit a transmitter ID corresponding to theanalyte sensor system. The one or more processors are configured toestablish a wireless connection with the health care provider devicebased on the transmitted transmitter ID being within a range oftransmitter IDs corresponding to currently deployed analyte sensorsystems. The one or more processors are configured to cause thetransceiver radio to transmit at least the logged analyte concentrationdata to the health care provider device.

In some embodiments, the magnetic sensor receives the wake signal at atime after the sensor session has concluded.

A method for wireless communication of continuous analyte data isprovided. The method includes periodically collecting raw data from ananalyte sensor for a duration of a sensor session. The method includesstoring the raw data. The method includes delaying conversion of the rawdata to estimated analyte values until at least after the sensor sessionhas concluded.

In some embodiments, the sensor session corresponds to an intendedusable life of the analyte sensor system.

A continuous analyte sensor system is provided. The system includes ananalyte sensor configured to periodically generate raw data for aduration of a sensor session. The system includes a storage configuredto store the raw data during the sensor session. The system includes oneor more processors configured to delay conversion of the raw data toestimated analyte values until at least after the sensor session hasconcluded.

A method for wireless communication of continuous analyte data isprovided. The method includes measuring at least one analyteconcentration value by an analyte sensor system during a sensor session.The method includes transmitting the at least one analyte concentrationvalue to a device associated with a health care provider utilizing acellular network connection.

In some embodiments, the at least one analyte concentration value is notdisplayed to a user of the analyte sensor system. In some embodiments,the at least one analyte concentration value is transmitted to thedevice associated with the health care provider after the sensor sessionhas concluded.

A continuous analyte sensor system is provided. The system includes ananalyte sensor configured to measure at least one analyte concentrationvalue during a sensor session. The system includes a cellular networkenabled transceiver radio. The system includes one or more processorsconfigured to cause the cellular-network enabled transceiver radio totransmit the at least one analyte concentration value to a deviceassociated with a health care provider utilizing a cellular networkconnection.

A method for wireless communication of data is provided. The methodincludes receiving, by an analyte sensor system, power via a near fieldcommunication from a first device. The method includes powering up atleast a portion of an analyte sensor system utilizing the receivedpower. The method includes transmitting data from the analyte sensorsystem to the first device, utilizing a first communication protocol,for use in troubleshooting a suspected malfunction of the analyte sensorsystem.

In some embodiments, the first communication protocol comprises aBluetooth low energy protocol.

A continuous analyte sensor system is provided. The system includes anear field communication circuit configured to receive power, via a nearfield communication, from a first device. The system includes atransceiver radio configured to be powered up by the received power. Thesystem includes one or more processors configured to cause thetransceiver radio to transmit data to the first device, utilizing afirst communication protocol, for use in troubleshooting a suspectedmalfunction of the analyte sensor system.

A method for wireless communication of continuous analyte data isprovided. The method includes disposing a display device sufficientlyclose to an analyte sensor system for a short-term wirelesscommunication protocol controller of the display device to transmitpower, utilizing the short-term wireless communication protocol, to theanalyte sensory system, thereby powering up at least a portion of theanalyte sensor system. The method includes receiving data from theanalyte sensor system via a first communication protocol. The methodincludes re-transmitting the data to a second device accessible to acustomer service representative, via a second communication protocol,for troubleshooting a suspected malfunction of the analyte sensorsystem.

In some embodiments, the first communication protocol comprises aBluetooth low energy protocol. In some embodiments, the secondcommunication protocol is Wi-Fi.

A display device is provided. The device includes a short-termcommunication protocol controller configured to transmit power,utilizing the short-term communication protocol, to an analyte sensorysystem when the display device is disposed sufficiently close to theanalyte sensor system, thereby powering up at least a portion of theanalyte sensor system. The device includes a transceiver radioconfigured to receive data from the analyte sensor system via a firstcommunication protocol. The device includes one or more processorsconfigured to cause the transceiver radio to re-transmit the data to asecond device accessible to a customer service representative, via asecond communication protocol, for troubleshooting a suspectedmalfunction of the analyte sensor system.

A method for wireless communication of continuous analyte concentrationdata is provided. The method includes transmitting at least one of awakeup signal and a first security code, as modulated visible light, toan analyte sensor system. The method includes receiving a secondsecurity code encrypted utilizing the first security code from theanalyte sensor system. The method includes verifying the encryptedsecond security code. The method includes establishing a securecommunication channel with the analyte sensor system responsive to theverifying. The method includes receiving analyte concentration data fromthe analyte sensor system over the secure communication channel.

In some embodiments, the encrypted second security code is receivedutilizing a communication protocol different from the modulated visiblelight. In some embodiments, the communication protocol is a BluetoothLow Energy protocol. In some embodiments, the analyte concentration datais received encrypted utilizing the second security code and wherein thesecure communication channel comprises a Bluetooth Low Energycommunication channel. In some embodiments, the wakeup signal and thefirst security code are transmitted as modulated visible light utilizinga display. In some embodiments, the modulated visible light comprisesone or more patterns of color, brightness or contrast displayed on thedisplay.

A display device is provided. The device includes a display configuredto transmit at least one of a wakeup signal and a first security code,as modulated visible light, to an analyte sensor system. The deviceincludes a transceiver radio configured to receiving a second securitycode encrypted utilizing the first security code from the analyte sensorsystem. The device includes one or more processors configured to verifythe encrypted second security code. The one or more processors areconfigured to establish a secure communication channel with the analytesensor system responsive to the verifying. The one or more processorsare configured to receive analyte concentration data from the analytesensor system over the secure communication channel.

A method for wireless communication of continuous analyte concentrationdata is provided. The method includes receiving at least one of a wakeupsignal and a first security code, as modulated visible light, from adisplay device. The method includes transmitting a second security codeencrypted utilizing the first security code from an analyte sensorsystem. The method includes establishing a secure communication channelwith the display device. The method includes transmitting analyteconcentration data over the secure communication channel.

In some embodiments, the encrypted second security code is transmittedutilizing a communication protocol different from the modulated visiblelight. In some embodiments, the communication protocol is a BluetoothLow Energy protocol. In some embodiments, the analyte concentration datais transmitted encrypted utilizing the second security code and whereinthe secure communication channel comprises a Bluetooth Low Energycommunication channel. In some embodiments, the wakeup signal and thefirst security code are received as modulated visible light utilizing alight sensor. In some embodiments, the modulated visible light comprisesone or more patterns of color, brightness or contrast displayed on adisplay of the display device.

A continuous analyte sensor system is provided. The system includes alight sensor configured to receive at least one of a wakeup signal and afirst security code, as modulated visible light, from a display device.The system includes a transceiver radio configured to transmit a secondsecurity code encrypted utilizing the first security code. The systemincludes one or more processors configured to establish a securecommunication channel with the analyte sensor system. The one or moreprocessors are configured to cause the transceiver radio to transmitanalyte concentration data over the secure communication channel.

A method for wireless communication with a continuous analyte sensorsystem is provided. The method includes receiving from a user, on afirst display device, an input indicative of a request to pair a seconddisplay device to the analyte sensor system. The method includestransmitting a first signal to the analyte sensory system indicatingthat the second display device has requested pairing. The methodincludes receiving a second signal from the second display deviceindicating the user has initiated a pairing process between the seconddisplay device and the analyte sensor system. The method includes,responsive to receiving the second signal from the second displaydevice, transmitting a transmitter ID corresponding to the analytesensor system to the second display device.

In some embodiments, the first display device comprises a smartphone,and the second display device comprises a smartwatch. In someembodiments, the second display device is configured to utilize thetransmitter ID to pair with the analyte sensor system.

A first display device is provided. The device includes an inputinterface configured to receive from a user an input indicative of arequest to pair a second display device to an analyte sensor system. Thedevice includes a transceiver radio configured to transmit a firstsignal to the analyte sensory system indicating that the second displaydevice has requested pairing. The device includes one or more processorsconfigured to receive a second signal from the second display deviceindicating the user has initiated a pairing process between the seconddisplay device and the analyte sensor system. The one or more processorsare configured to responsive to receiving the second signal from thesecond display device, cause the transceiver radio to transmit atransmitter ID corresponding to the analyte sensor system to the seconddisplay device.

A method for wireless communication with a continuous analyte sensorsystem is provided. The method includes receiving one or moreadvertisement messages from the analyte sensor system transmittedresponsive to a user selection on a first display device to pair asecond display device with the analyte sensor system. The methodincludes displaying a notification of a pairing process responsive toreceiving the one or more advertisement messages. The method includes,responsive to receiving an input for initiating the pairing process fromthe user, transmitting a signal indicating the input has been receivedfrom the user to the first display device. The method includes receivinga transmitter ID corresponding to the analyte sensor system from thefirst display device. The method includes establishing a secureconnection with the analyte sensor system utilizing the transmitter IDcorresponding to the analyte sensor system.

In some embodiments, the first display device comprises a smartphone,and the second display device comprises a smartwatch. In someembodiments, the second display device is configured to utilize thetransmitter ID to pair with the analyte sensor system.

A display device is provided. The device includes a transceiver radioconfigured to receive one or more advertisement messages from an analytesensor system transmitted responsive to a selection by a user on anotherdisplay device to pair the display device with the analyte sensorsystem. The device includes a display configured to display anotification of a pairing process responsive to the transceiver radioreceiving the one or more advertisement messages. The device includesone or more processors configured to responsive to receiving an inputfor initiating the pairing process from the user, cause the transceiverradio to transmit a signal indicating the input has been received fromthe user to the other display device. The one or more processors areconfigured to receive a transmitter ID corresponding to the analytesensor system from the first display device. The one or more processorsare configured to establish a secure connection with the analyte sensorsystem utilizing the transmitter ID corresponding to the analyte sensorsystem.

A method for wireless communication of continuous analyte concentrationdata is provided. The method includes transmitting one or more firstadvertising messages utilizing a first set of parameters during apredetermined communication interval if a whitelist of previouslyauthenticated devices has at least one unfilled entry. The methodincludes transmitting one or more second advertising messages utilizinga second set of parameters during the predetermined communicationinterval if the whitelist lists at least one device. The method includesestablishing a first communication session between an analyte sensorsystem and a first device and a second communication session between theanalyte sensor system and a second device during the predeterminedcommunication interval based on at least one of the first advertisingmessages and the second advertising messages. The method includestransmitting analyte concentration data to the first device and to thesecond device utilizing at least one of the first communication sessionand the second communication session during the predeterminedcommunication interval.

In some embodiments, the one or more first advertising messagesadvertise availability of the analyte sensor system for connection withone or more devices that are not currently listed on the whitelist andthe one or more second advertising messages advertise availability ofthe analyte sensor system for connection with one or more devicescurrently listed on the whitelist.

In some embodiments, the one or more first advertising messages aretransmitted after the one or more second advertising messages. In someembodiments, the one or more first advertising messages are transmittedbefore the one or more second advertising messages. In some embodiments,the method includes not transmitting the one or more first advertisingmessages during the predetermined communication interval if thewhitelist does not have at least one unfilled entry. In someembodiments, the method includes not transmitting the one or more secondadvertising messages during the predetermined communication interval ifthe whitelist does not currently list any devices. In some embodiments,the method includes not transmitting the one or more second advertisingmessages during the predetermined communication interval if all devicescurrently listed on the whitelist connected to the analyte sensor systemresponsive to the one or more first advertising messages.

In some embodiments, the first set of parameters define one or more of afirst duration of a first advertising interval for transmitting the oneor more first advertising messages, a first periodic interval fortransmission of the one or more first advertising messages, and a firstpower for transmission of the one or more first advertising messages. Insome embodiments, the second set of parameters define one or more of asecond duration of a second advertising interval for transmitting theone or more second advertising messages, a second periodic interval fortransmission of the one or more second advertising messages, and asecond power for transmission of the one or more second advertisingmessages. In some embodiments, the first power for transmission of theone or more first advertising messages is lower than the second powerfor transmission of the one or more second advertising messages. In someembodiments, devices utilized by consumers and devices utilized bymedical professionals are both eligible for inclusion in the whitelist.In some embodiments, the whitelist comprises 3 or more entries.

A continuous analyte sensor system configured for wireless communicationof analyte concentration data is provided. The system includes atransceiver radio configured to transmit one or more first advertisingmessages utilizing a first set of parameters during a predeterminedcommunication interval if a whitelist of previously authenticateddevices has at least one unfilled entry. The transceiver radio isconfigured to transmit one or more second advertising messages utilizinga second set of parameters during the predetermined communicationinterval if the whitelist lists at least one device. The system includesone or more processors configured to establish a first communicationsession between the analyte sensor system and a first device and asecond communication session between the analyte sensor system and asecond device based on at least one of the first advertising messagesand the second advertising messages. The one or more processors areconfigured to cause the transceiver radio to transmit analyteconcentration data to the first device and to the second deviceutilizing at least one of the first communication session and the secondcommunication session during the predetermined communication interval.

In some embodiments, the one or more processors are configured to causethe transceiver radio to not transmit the one or more first advertisingmessages during the predetermined communication interval if thewhitelist does not have at least one unfilled entry. In someembodiments, the one or more processors are configured to cause thetransceiver radio to not transmit the one or more second advertisingmessages during the predetermined communication interval if thewhitelist does not currently list any devices. In some embodiments, theone or more processors are configured to cause the transceiver radio tonot transmit the one or more second advertising messages during thepredetermined communication interval if all devices currently listed onthe whitelist connected to the analyte sensor system responsive to theone or more first advertising messages.

A method of communicating continuous analyte sensor data is provided.The method includes establishing a first communication session with afirst display device and a second communication session with a seconddisplay device, the second display device becoming unavailable forcommunication with the first device and with the analyte sensor systemfor a time period subsequent to establishing the second communicationsession. The method includes transmitting analyte sensor data to thefirst display device via the first communication session. The methodincludes storing the analyte sensor data at least during the timeperiod. The method includes transmitting the stored analyte sensor datato the second display device utilizing the second communication sessionresponsive to the second display device becoming available forcommunication with the analyte sensor system after the time period.

A continuous analyte sensor system is provided. The system includes atransceiver radio configured to establish a first communication sessionwith a first display device and a second communication session with asecond display device. The transceiver radio is configured to transmitanalyte sensor data to the first display device via the firstcommunication session. The system includes a storage configured to storethe analyte sensor data at least during a time period, subsequent toestablishing the second communication session, during which the seconddisplay device becomes unavailable for communication with the firstdevice and with the analyte sensor system. The system includes one ormore processor configured to cause the transceiver radio to transmit thestored analyte sensor data to the second display device utilizing thesecond communication session responsive to the second display devicebecoming available for communication with the analyte sensor systemafter the time period.

A method of communicating continuous analyte sensor data is provided.The method includes establishing a first communication session between afirst display device and an analyte sensor system and a thirdcommunication session between the first display device and a seconddisplay device, the second display device having established a secondcommunication session with the analyte sensor. The method includesreceiving analyte sensor data from the analyte sensor system via thefirst communication session, wherein the second display device becomesunavailable for communication with the first display device and with theanalyte sensor system for a time period subsequent to establishment ofthe second communication session. The method includes storing theanalyte sensor data at least during the time period. The method includestransmitting the stored analyte sensor data to the second display deviceutilizing the third communication session responsive to the seconddisplay device becoming available for communication over the thirdcommunication session after the time period.

A first display device is provided. The device includes a transceiverradio configured to establish a first communication session with ananalyte sensor system and a third communication session with a seconddisplay device, the second display device having established a secondcommunication session with the analyte sensor. The transceiver radio isconfigured to receive analyte sensor data from the analyte sensor systemvia the first communication session, wherein the second display devicebecomes unavailable for communication with the first device and with theanalyte sensor system for a time period subsequent to establishment ofthe second communication session. The device includes memory configuredto store the analyte sensor data at least during the time period. Thedevice includes one or more processors configured to transmit the storedanalyte sensor data to the second device utilizing the thirdcommunication session responsive to the second device becoming availablefor communication over the third communication session after the timeperiod.

A method of communicating continuous analyte sensor data is provided.The method includes establishing a first communication session with ananalyte sensor system and a second communication session with a firstdisplay device. The method includes becoming unavailable forcommunication with the first display device and with the analyte sensorsystem for a time period subsequent to establishment of the firstcommunication session. The method includes receiving analyte sensordata, previously stored by at least one of the first display device andthe analyte sensor system during the time period, over at least one ofthe first communication session and the second communication sessionresponsive to becoming available for communication over at least one ofthe first communication session and the second communication sessionafter the time period.

A first display device is provided. The device includes a transceiverradio configured to establish a first communication session with ananalyte sensor system and a second communication session with a firstdisplay device, wherein the first display device becomes unavailable forcommunication with the first device and with the analyte sensor systemfor a time period subsequent to establishment of the first communicationsession. The transceiver radio is configured to receive analyte sensordata, previously stored by at least one of the first device and theanalyte sensor system during the time period, over at least one of thefirst communication session and the second communication sessionresponsive to becoming available for communication over at least one ofthe first communication session and the second communication sessionafter the time period

A method of communicating continuous analyte sensor data is provided.The method includes determining that a first communication sessionbetween an analyte sensor system and a display device is to be closed.The method includes delaying the closing of the first communicationsession at least until after advertising messages have been transmitted.

In some embodiments, the determination that the first communicationsession is to be closed is made responsive to the first communicationsession being inactive for a predetermined period of time. In someembodiments, the determination that the first communication session isto be closed is made responsive to a mode of the analyte sensor systemchanging. In some embodiments, the mode of the analyte sensor changingcomprises the analyte sensor system transitioning from performing anactive glucose monitoring session to ending the active glucosemonitoring session. In some embodiments, the method includes, responsiveto the determining, preventing the first communication session frombeing closed based on receiving a plurality of heartbeat signals overthe first communication session after the determining. In someembodiments, the plurality of heartbeat signals are separated from oneanother by a first interval and the method includes receiving a secondplurality of heartbeat signals over the first communication sessionbefore the determining, the second plurality of heartbeat signalsseparated from one another by a second interval longer than the firstinterval.

A continuous analyte sensor system is provided. The system includes oneor more processors configured to determine that a first communicationsession between with a display device is to be closed and delaying theclosing of the first communication session at least until after the oneor more advertising messages have been transmitted.

BRIEF DESCRIPTION OF THE DRAWINGS

Further aspects of the present disclosure will be more readilyappreciated upon review of the detailed description of the variousdisclosed embodiments, described below, when taken in conjunction withthe accompanying figures.

FIG. 1A illustrates aspects of an example system that can be used inconnection with implementing embodiments of the disclosure;

FIG. 1B illustrates aspects of an example system that can be used inconnection with implementing embodiments of the disclosure;

FIG. 2A is a perspective view of an example enclosure that can be usedin connection with implementing embodiments of an analyte sensor system;

FIG. 2B is a cross-sectional view of an example enclosure that can beused in connection with implementing embodiments of an analyte sensorsystem;

FIG. 3A illustrates aspects of an example system that can be used inconnection with implementing embodiments of the disclosure;

FIG. 3B illustrates aspects of an example system that can be used inconnection with implementing embodiments of the disclosure;

FIG. 3C illustrates aspects of an example system that can be used inconnection with implementing embodiments of the disclosure;

FIG. 3D illustrates aspects of an example factory calibration systemthat can be used in connection with implementing embodiments of thedisclosure;

FIG. 3E illustrates aspects of an example factory testing system thatcan be used in connection with implementing embodiments of thedisclosure;

FIG. 4 is a block diagram illustrating aspects of an example analytesensor system according to embodiments of the disclosure;

FIG. 5 is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 6A is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 6B is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 7 is a signaling diagram illustrating various operations that canbe performed in accordance with embodiments of the disclosure;

FIG. 8A is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 8B is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 9 is a signaling diagram illustrating various operations that canbe performed in accordance with embodiments of the disclosure;

FIG. 10A is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 10B is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 11 illustrates a schematic circuit diagram illustrating aspects ofa portion of an example analyte sensor system according to embodimentsof the disclosure;

FIG. 12 is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 13 is a signaling diagram illustrating various operations that canbe performed in accordance with embodiments of the disclosure;

FIG. 14 is a signaling diagram illustrating various operations that canbe performed in accordance with embodiments of the disclosure;

FIG. 15A is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 15B is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 16 illustrates an NFC tag embedded in a sticker in accordance withembodiments of the disclosure;

FIG. 17 is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 18 illustrates aspects of an example system that can be used inconnection with implementing embodiments of the disclosure;

FIG. 19A is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 19B is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 20 is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 21A is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 21B is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 22A is a signaling diagram illustrating various operations that canbe performed in accordance with embodiments of the disclosure;

FIG. 22B is a signaling diagram illustrating various operations that canbe performed in accordance with embodiments of the disclosure;

FIG. 23 is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 24A is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 24B is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 24C is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 25 is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 26 illustrates aspects of an example system that can be used inconnection with implementing embodiments of the disclosure;

FIG. 27A is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 27B is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 28 is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 29 is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 30A is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 30B is an operational flow diagram illustrating various operationsthat can be performed in accordance with embodiments of the disclosure;

FIG. 31 illustrates an example computing module in accordance withembodiments of the present disclosure.

The figures are described in greater detail in the description andexamples below, are provided for purposes of illustration only, andmerely depict typical or example embodiments of the disclosure. Thefigures are not intended to be exhaustive or to limit the disclosure tothe precise form disclosed. It should also be understood that thedisclosure can be practiced with modification or alteration, and thatthe disclosure can be limited only by the claims and the equivalentsthereof.

DETAILED DESCRIPTION

Embodiments of the present disclosure are directed to systems, methods,and devices for wireless communication of analyte data. In variousdeployments described herein, the analyte data can be glucose datagenerated by an analyte sensor system configured to connect to displaydevices and the like. Implementing aspects of the present disclosure, asdescribed in detail herein, can reduce the power consumption of theanalyte sensor system by increasing the efficiency thereof with respectto wireless communications between the analyte sensor system and otherdevices. Moreover, implementing aspects of the present disclosure canalso allow for reduced power consumption while maintaining and/orimproving performance with respect to the reliability, speed, andaccuracy of wireless communications, as well as the connection protocolsassociated therewith. In particular, some such aspects of the disclosurerelate to, for example, authentication and encryption, connectionprotocols, advertisement message structure and content, device pairing,data transmission, data logging and the like.

The details of some example embodiments of the systems, methods, anddevices of the present disclosure are set forth in this description andin some cases, in other portions of the disclosure. Other features,objects, and advantages of the disclosure will be apparent to one ofskill in the art upon examination of the present disclosure,description, figures, examples, and claims. It is intended that all suchadditional systems, methods, devices, features, and advantages beincluded within this description (whether explicitly or by reference),be within the scope of the present disclosure, and be protected by oneor more of the accompanying claims.

Overview

In some embodiments, a system is provided for continuous measurement ofan analyte in a host. The system can include: a continuous analytesensor configured to continuously measure a concentration of the analytein the host, and a sensor electronics module physically connected to thecontinuous analyte sensor during sensor use. In certain embodiments, thesensor electronics module includes electronics configured to process adata stream associated with an analyte concentration measured by thecontinuous analyte sensor, in order to generate sensor information thatincludes raw sensor data, transformed sensor data, and/or any othersensor data, for example. The sensor electronics module can further beconfigured to generate sensor information that is customized forrespective display devices, such that different display devices canreceive different sensor information.

The term “analyte” as used herein is a broad term and is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and is not to be limited to a special or customized meaning), andfurthermore refers without limitation to a substance or chemicalconstituent in a biological fluid (for example, blood, interstitialfluid, cerebral spinal fluid, lymph fluid or urine) that can beanalyzed. Analytes can include naturally occurring substances,artificial substances, metabolites, and/or reaction products. In someembodiments, the analyte for measurement by the sensor heads, devices,and methods is analyte. However, other analytes are contemplated aswell, including but not limited to acarboxyprothrombin; acylcarnitine;adenine phosphoribosyl transferase; adenosine deaminase; albumin;alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle),histidine/urocanic acid, homocysteine, phenylalanine/tyrosine,tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers;arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactiveprotein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholicacid; chloroquine; cholesterol; cholinesterase; conjugated 1-13hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MMisoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine;dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcoholdehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Beckermuscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A,hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F,D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1,Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax,sexual differentiation, 21-deoxycortisol); desbutylhalofantrine;dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocytearginase; erythrocyte protoporphyrin; esterase D; fattyacids/acylglycines; free 13-human chorionic gonadotropin; freeerythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine(FT3); fumarylacetoacetase; galactose/gal-1-phosphate;galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphatedehydrogenase; glutathione; glutathione perioxidase; glycocholic acid;glycosylated hemoglobin; halofantrine; hemoglobin variants;hexosaminidase A; human erythrocyte carbonic anhydrase I;17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase;immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, ß);lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin;phytanic/pristanic acid; progesterone; prolactin; prolidase; purinenucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);selenium; serum pancreatic lipase; sissomicin; somatomedin C; specificantibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody,arbovirus, Aujeszky's disease virus, dengue virus, Dracunculusmedinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmaniadonovani, leptospira, measles/mumps/rubella, Mycobacterium leprae,Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenzavirus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa,respiratory syncytial virus, rickettsia (scrub typhus), Schistosomamansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosomacruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellowfever virus); specific antigens (hepatitis B virus, HIV-1);succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine(T4); thyroxine-binding globulin; trace elements; transferring;UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A;white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat,vitamins, and hormones naturally occurring in blood or interstitialfluids can also constitute analytes in certain embodiments. The analytecan be naturally present in the biological fluid, for example, ametabolic product, a hormone, an antigen, an antibody, and the like.Alternatively, the analyte can be introduced into the body, for example,a contrast agent for imaging, a radioisotope, a chemical agent, afluorocarbon-based synthetic blood, or a drug or pharmaceuticalcomposition, including but not limited to insulin; ethanol; cannabis(marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide,amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine(crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin,Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine);depressants (barbiturates, methaqualone, tranquilizers such as Valium,Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens(phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics(heroin, codeine, morphine, opium, meperidine, Percocet, Percodan,Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogsof fentanyl, meperidine, amphetamines, methamphetamines, andphencyclidine, for example, Ecstasy); anabolic steroids; and nicotine.The metabolic products of drugs and pharmaceutical compositions are alsocontemplated analytes. Analytes such as neurochemicals and otherchemicals generated within the body can also be analyzed, such as, forexample, ascorbic acid, uric acid, dopamine, noradrenaline,3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC),Homovanillic acid (HVA), 7-Hydroxytryptamine (5HT), and7-Hydroxyindoleacetic acid (FHIAA).

Alerts

In certain embodiments, one or more alerts are associated with a sensorelectronics module. For example, each alert can include one or morealert conditions that indicate when the respective alert has beentriggered. For example, a hypoglycemic alert can include alertconditions indicating a minimum glucose level. The alert conditions canalso be based on transformed sensor data, such as trending data, and/orsensor data from multiple different sensors (e.g. an alert can be basedon sensor data from both a glucose sensor and a temperature sensor). Forexample, a hypoglycemic alert can include alert conditions indicating aminimum required trend in the host's glucose level that must be presentbefore triggering the alert. The term “trend,” as used herein refersgenerally to data indicating some attribute of data that is acquiredover time, e.g., such as calibrated or filtered data from a continuousglucose sensor. A trend can indicate amplitude, rate of change,acceleration, direction, etc., of data, such as sensor data, includingtransformed or raw sensor data.

In certain embodiments, each of the alerts is associated with one ormore actions that are to be performed in response to triggering of thealert. Alert actions can include, for example, activating an alarm, suchas displaying information on a display of the sensor electronics moduleor activating an audible or vibratory alarm coupled to the sensorelectronics module, and/or transmitting data to one or more displaydevices external to the sensor electronics module. For any deliveryaction that is associated with a triggered alert, one or more deliveryoptions define the content and/or format of the data to be transmitted,the device to which the data is to be transmitted, when the data is tobe transmitted, and/or a communication protocol for delivery of thedata.

In certain embodiments, multiple delivery actions (each havingrespective delivery options) can be associated with a single alert suchthat displayable sensor information having different content andformatting, for example, is transmitted to respective display devices inresponse to triggering of a single alert. For example, a mobiletelephone can receive a data package including minimal displayablesensor information (that can be formatted specifically for display onthe mobile telephone), while a desktop computer can receive a datapackage including most (or all) of the displayable sensor informationthat is generated by the sensor electronics module in response totriggering of a common alert. Advantageously, the sensor electronicsmodule is not tied to a single display device, rather it is configuredto communicate with a plurality of different display devices directly,systematically, simultaneously (e.g., via broadcasting), regularly,periodically, randomly, on-demand, in response to a query, based onalerts or alarms, and/or the like.

In some embodiments, clinical risk alerts are provided that includealert conditions that combine intelligent and dynamic estimativealgorithms that estimate present or predicted danger with greateraccuracy, more timeliness in pending danger, avoidance of false alarms,and less annoyance for the patient. In general, clinical risk alertsinclude dynamic and intelligent estimative algorithms based on analytevalue, rate of change, acceleration, clinical risk, statisticalprobabilities, known physiological constraints, and/or individualphysiological patterns, thereby providing more appropriate, clinicallysafe, and patient-friendly alarms. U.S. Patent Publication No.2007/0208246, which is incorporated herein by reference in its entirety,describes some systems and methods associated with the clinical riskalerts (or alarms) described herein. In some embodiments, clinical riskalerts can be triggered for a predetermined time period to allow for theuser to attend to his/her condition. Additionally, the clinical riskalerts can be de-activated when leaving a clinical risk zone so as notto annoy the patient by repeated clinical alarms (e.g., visual, audibleor vibratory), when the patient's condition is improving. In someembodiments, dynamic and intelligent estimation determines a possibilityof the patient avoiding clinical risk, based on the analyteconcentration, the rate of change, and other aspects of the dynamic andintelligent estimative algorithms. If there is minimal or no possibilityof avoiding the clinical risk, a clinical risk alert will be triggered.However, if there is a possibility of avoiding the clinical risk, thesystem is configured to wait a predetermined amount of time andre-analyze the possibility of avoiding the clinical risk. In someembodiments, when there is a possibility of avoiding the clinical risk,the system is further configured to provide targets, therapyrecommendations, or other information that can aid the patient inproactively avoiding the clinical risk.

In some embodiments, the sensor electronics module is configured tosearch for one or more display devices within communication range of thesensor electronics module and to wirelessly communicate sensorinformation (e.g., a data package including displayable sensorinformation, one or more alarm conditions, and/or other alarminformation) thereto. Accordingly, the display device is configured todisplay at least some of the sensor information and/or alarm the host(and/or caretaker), wherein the alarm mechanism is located on thedisplay device.

In some embodiments, the sensor electronics module is configured toprovide one or a plurality of different alarms via the sensorelectronics module and/or via transmission of a data package indicatingan alarm should be initiated by one or a plurality of display devices(e.g., sequentially and/or simultaneously). In certain embodiments, thesensor electronics module merely provides a data field indicating thatan alarm conditions exists and the display device, upon reading the datafield indicating the existence of the alarm condition, can decide totrigger an alarm. In some embodiments, the sensor electronics moduledetermines which of the one or more alarms to trigger based on one ormore alerts that are triggered. For example, when an alert triggerindicates severe hypoglycemia, the sensor electronics module can performmultiple actions, such as activating an alarm on the sensor electronicsmodule, transmitting a data package to a monitoring device indicatingactivation of an alarm on the display, and transmitting a data packageas a text message to a care provider. As an example, a text message canappear on a custom monitoring device, cell phone, pager device, and/orthe like, including displayable sensor information that indicates thehost's condition (e.g., “severe hypoglycemia”).

In some embodiments, the sensor electronics module is configured to waita time period for the host to respond to a triggered alert (e.g., bypressing or selecting a snooze and/or off function and/or button on thesensor electronics module and/or a display device), after whichadditional alerts are triggered (e.g., in an escalating manner) untilone or more alerts are responded to. In some embodiments, the sensorelectronics module is configured to send control signals (e.g., a stopsignal) to a medical device associated with an alarm condition (e.g.,hypoglycemia), such as an insulin pump, wherein the stop alert triggersa stop of insulin delivery via the pump.

In some embodiments, the sensor electronics module is configured todirectly, systematically, simultaneously (e.g., via broadcasting),regularly, periodically, randomly, on-demand, in response to a query(from the display device), based on alerts or alarms, and/or the like,transmit alarm information. In some embodiments, the system furtherincludes a repeater such that the wireless communication distance of thesensor electronics module can be increased, for example, to 10, 20, 30,70 75, 100, 150, or 200 meters or more, wherein the repeater isconfigured to repeat a wireless communication from the sensorelectronics module to the display device located remotely from thesensor electronics module. A repeater can be useful to families havingchildren with diabetes. For example, to allow a parent to carry, orplace in a stationary position, a display device, such as in a largehouse wherein the parents sleep at a distance from the child.

Display Devices

In some embodiments, the sensor electronics module is configured tosearch for and/or attempt wireless communication with a display devicefrom a list of display devices. In some embodiments, the sensorelectronics module is configured to search for and/or attempt wirelesscommunication with a list of display devices in a predetermined and/orprogrammable order (e.g., grading and/or escalating), for example,wherein a failed attempt at communication with and/or alarming with afirst display device triggers an attempt at communication with and/oralarming with a second display device, and so on. In one exampleembodiment, the sensor electronics module is configured to search forand attempt to alarm a host or care provider sequentially using a listof display devices, such as: (1) a default display device or a customanalyte monitoring device; (2) a mobile phone via auditory and/or visualmethods, such as, text message to the host and/or care provider, voicemessage to the host and/or care provider, and/or 911); (3) a tablet; (4)a smart watch.

Depending on the embodiment, one or more display devices that receivedata packages from the sensor electronics module are “dummy displays”,wherein they display the displayable sensor information received fromthe sensor electronics module without additional processing (e.g.,prospective algorithmic processing necessary for real-time display ofsensor information). In some embodiments, the displayable sensorinformation comprises transformed sensor data that does not requireprocessing by the display device prior to display of the displayablesensor information. Some display devices can include software includingdisplay instructions (software programming comprising instructionsconfigured to display the displayable sensor information and optionallyquery the sensor electronics module to obtain the displayable sensorinformation) configured to enable display of the displayable sensorinformation thereon. In some embodiments, the display device isprogrammed with the display instructions at the manufacturer and caninclude security and/or authentication to avoid plagiarism of thedisplay device. In some embodiments, a display device is configured todisplay the displayable sensor information via a downloadable program(for example, a downloadable Java Script, app, etc. via the internetsuch as but not limited to an Appstore or Google Play), such that anydisplay device that supports downloading of a program (for example, anydisplay device that supports Java applets) therefore can be configuredto display displayable sensor information (e.g., mobile phones, tablets,PDAs, PCs and the like).

In some embodiments, certain display devices can be in direct wirelesscommunication with the sensor electronics module, but intermediatenetwork hardware, firmware, and/or software can be included within thedirect wireless communication. In some embodiments, a repeater (e.g., aBluetooth repeater) can be used to re-transmit the transmitteddisplayable sensor information to a location farther away than theimmediate range of the telemetry module of the sensor electronicsmodule, wherein the repeater enables direct wireless communication whensubstantive processing of the displayable sensor information does notoccur. In some embodiments, a receiver (e.g., Bluetooth receiver) can beused to re-transmit the transmitted displayable sensor information,possibly in a different format, such as in a text message onto a TVscreen, wherein the receiver enables direct wireless communication whensubstantive processing of the sensor information does not occur. Incertain embodiments, the sensor electronics module directly wirelesslytransmits displayable sensor information to one or a plurality ofdisplay devices, such that the displayable sensor informationtransmitted from the sensor electronics module is received by thedisplay device without intermediate processing of the displayable sensorinformation.

In certain embodiments, one or more display devices include built-inauthentication mechanisms, wherein authentication is required forcommunication between the sensor electronics module and the displaydevice. In some embodiments, to authenticate the data communicationbetween the sensor electronics module and display devices, achallenge-response protocol, such as key authentication is provided,where the challenge is a request for the key or a hash or other valuebased on or derived from the key, and the valid response is the correctkey or a hash or other value based on or derived from the key, such thatpairing of the sensor electronics module with the display devices can beaccomplished by the user and/or manufacturer via the key. This can bereferred to in some cases as two-way authentication. The key can be asoftware or hardware level key. Additionally, the key can be a password(e.g., randomly generated or set by a user or other entity), and/or canbe derived from uniquely identifying features (e.g., fingerprint orretinal information) or information, etc.

In some embodiments, one or more display devices are configured to querythe sensor electronics module for displayable sensor information,wherein the display device acts as a master device requesting sensorinformation from the sensor electronics module (e.g., a slave device)on-demand, for example, in response to a query. Although in some casesthe display device acts as a master and the sensor electronics moduleacts as a slave, in other cases, these roles can be reversed. Forexample, the roles can reverse depending on the nature of thecommunication and so on. In some embodiments, the sensor electronicsmodule is configured for periodic, systematic, regular, and/or periodictransmission of sensor information to one or more display devices (forexample, every 30 seconds, 1, 2, 7, or 10 minutes or more). In someembodiments, the sensor electronics module is configured to transmitdata packages associated with a triggered alert (e.g., triggered by oneor more alert conditions). However, any combination of the abovedescribed statuses of data transmission can be implemented with anycombination of paired sensor electronics module and display device(s),or between display devices themselves. For example, one or more displaydevices can be configured for querying the sensor electronics moduledatabase and for receiving alarm information triggered by one or morealarm conditions being met. Additionally, the sensor electronics modulecan be configured for periodic transmission of sensor information to oneor more display devices (the same or different display devices asdescribed in the previous example), whereby a system can include displaydevices that function differently regarding how sensor information isobtained.

In some embodiments, a display device is configured to query the datastorage memory in the sensor electronics module for certain types ofdata content, including direct queries into a database in the sensorelectronics module's memory and/or requests for configured orconfigurable packages of data content therefrom; namely, the data storedin the sensor electronics module is configurable, queryable,predetermined, and/or pre-packaged, based on the display device withwhich the sensor electronics module is communicating. In some additionalor alternative embodiments, the sensor electronics module generates thedisplayable sensor information based on its knowledge of which displaydevice is to receive a particular transmission. Additionally, somedisplay devices are capable of obtaining calibration information andwirelessly transmitting the calibration information to the sensorelectronics module, such as through manual entry of the calibrationinformation, automatic delivery of the calibration information, and/oran integral reference analyte monitor incorporated into the displaydevice. U.S. Patent Publication Nos. 2006/0222566, 2007/0203966,2007/0208245, and 2005/0154271, all of which are incorporated herein byreference in their entirety, describe systems and methods for providingan integral reference analyte monitor incorporated into a display deviceand/or other calibration methods that can be implemented withembodiments disclosed herein. In some embodiments, such sensorelectronics modules may be factory calibrated such that calibrationinformation need not be transmitted to the sensor electronics module.

In general, a plurality of display devices (e.g., a custom analytemonitoring device (which can also be referred to as an analyte displaydevice), a mobile phone, a tablet, a smart watch, a reference analytemonitor, a drug delivery device, a medical device and a personalcomputer) can be configured to wirelessly communicate with the sensorelectronics module. The plurality of display devices can be configuredto display at least some of the displayable sensor informationwirelessly communicated from the sensor electronics module. Thedisplayable sensor information can include sensor data, such as raw dataand/or transformed sensor data, such as analyte concentration values,rate of change information, trend information, alert information, sensordiagnostic information and/or calibration information, for example.

Continuous Sensor

With reference to FIG. 1A, in some embodiments, analyte sensor 10includes a continuous glucose sensor, for example, a subcutaneous,transdermal (e.g., transcutaneous), or intravascular device. In someembodiments, such a sensor or device can analyze a plurality ofintermittent blood samples. The glucose sensor can use any method ofglucose-measurement, including enzymatic, chemical, physical,electrochemical, spectrophotometric, polarimetric, calorimetric,iontophoretic, radiometric, immunochemical, and the like.

A glucose sensor can use any known method, including invasive, minimallyinvasive, and non-invasive sensing techniques (e.g., fluorescentmonitoring), to provide a data stream indicative of the concentration ofglucose in a host. The data stream is typically a raw data signal, whichis converted into a calibrated and/or filtered data stream that is usedto provide a useful value of glucose to a user, such as a patient or acaretaker (e.g., a parent, a relative, a guardian, a teacher, a doctor,a nurse, or any other individual that has an interest in the wellbeingof the host).

A glucose sensor can be any device capable of measuring theconcentration of glucose. According to one example embodiment describedbelow, an implantable glucose sensor can be used. However, it should beunderstood that the devices and methods described herein can be appliedto any device capable of detecting a concentration of glucose andproviding an output signal that represents the concentration of glucose(e.g., as a form of analyte data).

In certain embodiments, analyte sensor 10 is an implantable glucosesensor, such as described with reference to U.S. Pat. No. 8,001,067 andU.S. Patent Publication No. US-2005-0027463-A1. In embodiments, analytesensor 10 is a transcutaneous glucose sensor, such as described withreference to U.S. Patent Publication No. US-2006-0020187-A1. Inembodiments, analyte sensor 10 is configured to be implanted in a hostvessel or extracorporeally, such as is described in U.S. PatentPublication No. US-2007-0027385-A1, co-pending U.S. Patent PublicationNo. US-2008-0119703-A1 filed Oct. 4, 2006, U.S. Patent Publication No.US-2008-0108942-A1 filed on Mar. 26, 2007, and U.S. Patent ApplicationNo. US-2007-0197890-A1filed on Feb. 14, 2007. In embodiments, thecontinuous glucose sensor includes a transcutaneous sensor such asdescribed in U.S. Pat. No. 8,565,509 to Say et al., for example. Inembodiments, analyte sensor 10 is a continuous glucose sensor thatincludes a subcutaneous sensor such as described with reference to U.S.Pat. No. 8,579,690 to Bonnecaze et al. or U.S. Pat. No. 8,484,046 to Sayet al., for example. In embodiments, the continuous glucose sensorincludes a refillable subcutaneous sensor such as described withreference to U.S. Pat. No. 8,512,939 to Colvin et al., for example. Thecontinuous glucose sensor can include an intravascular sensor such asdescribed with reference to U.S. Pat. No. 8,477,395 to Schulman et al.,for example. The continuous glucose sensor can include an intravascularsensor such as described with reference to U.S. Pat. No. 8,424,847 toMastrototaro et al., for example.

FIGS. 2A and 2B are perspective and cross-sectional views of enclosure200 that can be used in connection with implementing embodiments ofanalyte sensor system 8, according certain aspects of the presentdisclosure. Enclosure 200 includes mounting unit 214 and sensorelectronics module 12 attached thereto in certain embodiments. Enclosure200 is shown in a functional position, including mounting unit 214 andsensor electronics module 12 matingly engaged therein. In someembodiments, mounting unit 214, also referred to as a housing or sensorpod, includes base 234 adapted for fastening to a host's or user's skin.Base 234 can be formed from a variety of hard or soft materials and caninclude a low profile for minimizing protrusion of the device from thehost during use. In some embodiments, base 234 is formed at leastpartially from a flexible material, which can provide numerousadvantages over other transcutaneous sensors, which, unfortunately, cansuffer from motion-related artifacts associated with the host's movementwhen the host is using the device. Mounting unit 214 and/or sensorelectronics module 12 can be located over the sensor insertion site toprotect the site and/or provide a minimal footprint (utilization ofsurface area of the host's skin).

In some embodiments, a detachable connection between mounting unit 214and sensor electronics module 12 is provided, which enables improvedmanufacturability, namely, the potentially relatively inexpensivemounting unit 214 can be disposed of when refurbishing or maintaininganalyte sensor system 8, while the relatively more expensive sensorelectronics module 12 can be reusable with multiple sensor systems. Insome embodiments, sensor electronics module 12 is configured with signalprocessing (programming), for example, configured to filter, calibrate,and/or execute other algorithms useful for calibration and/or display ofsensor information. However, an integral (non-detachable) sensorelectronics module can be configured.

In some embodiments, contacts 238 are mounted on or in a subassemblyhereinafter referred to as contact subassembly 236 configured to fitwithin base 234 of mounting unit 214 and hinge 248 that allows contactsubassembly 236 to pivot between a first position (for insertion) and asecond position (for use) relative to mounting unit 214. The term“hinge” as used herein is a broad term and is used in its ordinarysense, including, without limitation, to refer to any of a variety ofpivoting, articulating, and/or hinging mechanisms, such as an adhesivehinge, a sliding joint, and the like; the term hinge does notnecessarily imply a fulcrum or fixed point about which the articulationoccurs. In some embodiments, contacts 238 are formed from a conductiveelastomeric material, such as a carbon black elastomer, through whichsensor 10 extends.

With further reference to FIG. 2A, in certain embodiments, mounting unit214 is provided with adhesive pad 208, disposed on the mounting unit'sback surface and includes a releasable backing layer. Thus, removing thebacking layer and pressing at last a portion of base 234 of mountingunit 214 onto the host's skin adheres mounting unit 214 to the host'sskin. Additionally, or alternatively, an adhesive pad can be placed oversome or all of analyte sensor system 8 and/or sensor 10 after sensorinsertion is complete to ensure adhesion, and optionally to ensure anairtight seal or watertight seal around the wound exit-site (or sensorinsertion site) (not shown). Appropriate adhesive pads can be chosen anddesigned to stretch, elongate, conform to, and/or aerate the region(e.g., host's skin). The embodiments described with reference to FIGS.2A and 2B are described in more detail with reference to U.S. Pat. No.7,310,544, which is incorporated herein by reference in its entirety.Configurations and arrangements can provide water resistant, waterproof,and/or hermetically sealed properties associated with the mountingunit/sensor electronics module embodiments described herein.

Various methods and devices that are suitable for use in conjunctionwith aspects of some embodiments are disclosed in U.S. PatentPublication No. US-2009-0240120-A1, which is incorporated herein byreference in its entirety for all purposes.

Example Configurations

Referring again to FIG. 1A, system 100 that can be used in connectionwith implementing aspects of an analyte sensor system is depicted. Insome cases, system 100 can be used to implement various systemsdescribed herein. System 100 in embodiments includes analyte sensorsystem 8, display devices 110, 120, 130, and 140 according to certainaspects of the present disclosure. Analyte sensor system 8 in theillustrated embodiment includes sensor electronics module 12 andcontinuous analyte sensor 10 associated with the sensor electronicsmodule 12. Sensor electronics module 12 can be in wireless communication(e.g., directly or indirectly) with one or more of display devices 110,120, 130, and 140. In embodiments, system 100 also includes medicaldevice 136, health care provider device 150, server system 134, factorytesting station 351, and factory calibration station 381. Sensorelectronics module 12 can also be in wireless communication (e.g.,directly or indirectly) with medical device 136, health care providerdevice 150, server system 134. Likewise, in some examples, displaydevices 110-140 can also be in wireless communication (e.g., directly orindirectly) with medical device 136, health care provider device 150,server system 134. Various couplings shown in FIG. 1A can be facilitatedwith wireless access point 138, as also mentioned below.

In certain embodiments, sensor electronics module 12 includes electroniccircuitry associated with measuring and processing the continuousanalyte sensor data, including prospective algorithms associated withprocessing and calibration of the sensor data. Sensor electronics module12 can be physically connected to continuous analyte sensor 10 and canbe integral with (non-releasably attached to) or releasably attachableto continuous analyte sensor 10. Sensor electronics module 12 caninclude hardware, firmware, and/or software that enables measurement oflevels of the analyte via a glucose sensor. For example, sensorelectronics module 12 can include a potentiostat, a power source forproviding power to the sensor, other components useful for signalprocessing and data storage, and a telemetry module for transmittingdata from the sensor electronics module to one or more display devices.Electronics can be affixed to a printed circuit board (PCB), or thelike, and can take a variety of forms. For example, the electronics cantake the form of an integrated circuit (IC), such as anApplication-Specific Integrated Circuit (ASIC), a microcontroller,and/or a processor.

Sensor electronics module 12 can include sensor electronics that areconfigured to process sensor information, such as sensor data, andgenerate transformed sensor data and displayable sensor information.Examples of systems and methods for processing sensor analyte data aredescribed in more detail herein and in U.S. Pat. Nos. 7,310,544 and8,931,327 and U.S. Patent Publication Nos. 2005/0043598, 2007/0032706,2007/0016381, 2008/0033254, 2005/0203360, 2005/0154271, 2005/0192557,2006/0222566, 2007/0203966 and 2007/0208245, all of which areincorporated herein by reference in their entirety for all purposes.

Referring again to FIG. 1A, display devices 110, 120, 130, and/or 140are configured for displaying (and/or alarming) the displayable sensorinformation that can be transmitted by sensor electronics module 12(e.g., in a customized data package that is transmitted to the displaydevices based on their respective preferences). Each of display devices110, 120, 130, or 140 can include a display such as a touchscreendisplay 112, 122, 132, /or 142 for displaying sensor information and/oranalyte data to a user and/or receiving inputs from the user. Forexample, a graphical user interface can be presented to the user forsuch purposes. In some embodiments, the display devices can includeother types of user interfaces such as voice user interface instead ofor in addition to a touchscreen display for communicating sensorinformation to the user of the display device and/or receiving userinputs. In some embodiments, one, some, or all of the display devices isconfigured to display or otherwise communicate the sensor information asit is communicated from the sensor electronics module (e.g., in a datapackage that is transmitted to respective display devices), without anyadditional prospective processing required for calibration and real-timedisplay of the sensor data.

Medical device 136 can be a passive device in example embodiments of thedisclosure. For example, medical device 136 can be an insulin pump foradministering insulin to a user, as shown in FIG. 1B. For a variety ofreasons, it can be desirable for such an insulin pump to receive andtrack glucose values transmitted from analyte sensor system 8. Onereason is to provide the insulin pump a capability to suspend/activateinsulin administration based on a glucose value being below/above athreshold value. One solution that allows a passive device (e.g.,medical device 136) to receive analyte data (e.g., glucose values)without being bonded to analyte sensor system 8 is to include theanalyte data in the advertisement messages transmitted from analytesensor system 8. The data included in the advertisement messages can beencoded so that only a device that has the identification informationassociated with analyte sensor system 8 can decode the analyte data.Medical device 136 can include input/output portion 136 a, in which, forexample, glucose and other values can be displayed and input can bereceived via buttons, wireless connection, or other mechanisms. Medicaldevice 136 can also include attachment portion 136 b that interfaceswith the user to, for example, administrate insulin responsive to theinput received at input/output portion 136 a. In some cases, attachmentportion 136 b can provide sensory alerts or other notifications to theuser based on, for example, the input received and/or values calculatedat input/output portion 136 a.

Health care provider device 150 can be utilized by health care providersto track, log, and/or otherwise analyze data provided by one or moreanalyte sensor systems, as disclosed herein. Several example embodimentsof health care provider device 150 will be described in more detail inconnection with FIGS. 26-27B below.

Factory calibration station 381 can be utilized to calibrate one or moreanalyte sensor systems, as disclosed herein. Several example embodimentsof factory calibration station 381 will be described in more detail inconnection with FIGS. 3D and 5 below.

Factory testing station 351 can be utilized to test one or more analytesensor systems, as disclosed herein. Several example embodiments offactory testing station 351 will be described in more detail inconnection with FIGS. 3E, 6A and 6B below.

With further reference to FIG. 1A, the plurality of display devices caninclude a custom display device specially designed for displayingcertain types of displayable sensor information associated with analytedata received from sensor electronics module 12 (e.g., a numerical valueand an arrow, in some embodiments). Analyte display device 110 is anexample of such a custom device. In some embodiments, one of theplurality of display devices is a smartphone, such as mobile phone 120based on an Android, iOS or other operating system, and configured todisplay a graphical representation of the continuous sensor data (e.g.,including current and historic data). Other display devices can includeother hand-held devices, such as tablet 130, smart watch 140, medicaldevice 136 (e.g., an insulin delivery device or a blood glucose meter),and/or a desktop or laptop computer.

Because different display devices provide different user interfaces,content of the data packages (e.g., amount, format, and/or type of datato be displayed, alarms, and the like) can be customized (e.g.,programmed differently by the manufacture and/or by an end user) foreach particular display device. Accordingly, in the embodiment of FIG.1A, a plurality of different display devices can be in direct wirelesscommunication with a sensor electronics module (e.g., such as an on-skinsensor electronics module 12 that is physically connected to thecontinuous analyte sensor 10) during a sensor session to enable aplurality of different types and/or levels of display and/orfunctionality associated with the displayable sensor information, whichis described in more detail elsewhere herein.

As further illustrated in FIG. 1A, system 100 can also include wirelessaccess point (WAP) 138 that can be used to couple one or more of analytesensor system 8, the plurality display devices, server system 134, andmedical device 136 to one another. For example, WAP 138 can provideWi-Fi and/or cellular connectivity within system 100. Near FieldCommunication (NFC) can also be used among devices of system 100. Serversystem 134 can be used to collect analyte data from analyte sensorsystem 8 and/or the plurality of display devices, for example, toperform analytics thereon, generate universal or individualized modelsfor glucose levels and profiles, and so on.

Referring now to FIG. 3A, system 300 is depicted. System 300 can be usedin connection with implementing embodiments of the disclosed systems,methods, and devices. By way of example, the various below-describedcomponents of FIG. 3A can be used to provide wireless communication ofglucose data, for example between an analyte sensor system and aplurality of display devices, medical devices, servers and so on.

As shown in FIG. 3A, system 100 can include analyte sensor system 308and one or more display devices 310. Additionally, in the illustratedembodiment, system 300 includes server system 334, which in turnincludes server 334 a coupled to processor 334 c and storage 334 b.Analyte sensor system 308 can be coupled to display devices 310 and/orserver system 334 via communication medium 305.

As will be described in detail herein, analyte sensor system 308 anddisplay devices 310 can exchange messaging via communication medium 305,and communication medium 305 can also be used to deliver analyte data todisplay devices 310 and/or server system 334. Display devices 310 caninclude a variety of electronic computing devices, such as, for example,a smartphone, tablet, laptop, wearable device such as a smartwatch, etc.Display devices 310 can also include analyte display device 110, medicaldevice 136, health care provider device 150, server system 134, factorytesting station 351, and factory calibration station 381. Here, it willbe noted that a graphical user interface (GUI) of display device 310 canperform such functions as accepting user input and displaying menus aswell as information derived from analyte data. The GUI can be providedby various operating systems known in the art, such as, for example,iOS, Android, Windows Mobile, Windows, Mac OS, Chrome OS, Linux, Unix, agaming platform OS (e.g., Xbox, PlayStation, Wii), etc. In variousembodiments, communication medium 305 can be based on one or morewireless communication protocols such as Bluetooth, Bluetooth Low Energy(BLE), ZigBee, Wi-Fi, 802.11 protocols, Infrared (IR), Radio Frequency(RF), 2G, 3E, 4G, 7G etc., and/or wired protocols and media.

In various embodiments, the elements of system 300 can be used toperform various processes described herein and/or can be used to executevarious operations described herein regarding one or more disclosedsystems and methods. Upon studying the present disclosure, one of skillin the art will appreciate that system 300 can include multiple analytesensor systems, communication media 305 for communication utilizing thesame or different communication protocols, and/or server systems 334.

As mentioned, communication medium 305 can be used to connect orcommunicatively couple analyte sensor system 308, display devices 310,and/or server system 334 to one another or to a network, andcommunication medium 305 can be implemented in a variety of forms. Forexample, communication medium 305 can include an Internet connection,such as a local area network (LAN), a wide area network (WAN), a fiberoptic network, internet over power lines, a hard-wired connection (e.g.,a bus), and the like, or any other kind of network connection.Communication medium 305 can be implemented using any combination ofrouters, cables, modems, switches, fiber optics, wires, radio (e.g.,microwave/RF links), and the like. Further, communication medium 305 canbe implemented using various wireless standards, such as Bluetooth®,BLE, Wi-Fi, 3EPP standards (e.g., 2G GSM/GPRS/EDGE, 3E UMTS/CDMA2000, 4GLTE/LTE-U, 5G), etc. Upon reading the present disclosure, one of skillin the art will recognize other ways to implement communication medium305 for communications purposes.

Server 334 a can receive, collect, or monitor information, includinganalyte data and related information, from analyte sensor system 308and/or display device 310, such as input responsive to the analyte dataor input received in connection with an analyte monitoring applicationrunning on analyte sensor system or display device 310. In such cases,server 334 a can be configured to receive such information viacommunication medium 305. This information can be stored in storage 334b and can be processed by processor 334 c. For example, processor 334 ccan include an analytics engine capable of performing analytics oninformation that server 334 a has collected, received, etc. viacommunication medium 305. In embodiments, server 334 a, storage 334 b,and/or processor 334 c can be implemented as a distributed computingnetwork, such as a Hadoop® network, or as a relational database or thelike.

Server 334 a can include, for example, an Internet server, a router, adesktop or laptop computer, a smartphone, a tablet, a processor, amodule, or the like, and can be implemented in various forms, including,for example, an integrated circuit or collection thereof, a printedcircuit board or collection thereof, or in a discretehousing/package/rack or multiple of the same. In embodiments, server 334a at least partially directs communications made over communicationmedium 305. Such communications include the delivery and/or messaging(e.g., advertisement, command, or other messaging) and analyte data. Forexample, server 334 a can process and exchange messages between analytesensor system 308 and display devices 310 related to frequency bands,timing of transmissions, security, alarms, and so on. Server 334 a canupdate and/or provide information stored on analyte sensor system 308and/or display devices 310, for example, by delivering applications,security codes, transmitter IDs, pairing keys, etc. thereto. Server 334a can send/receive information to/from analyte sensor system 308 and/ordisplay devices 310 in real time or sporadically. Further, server 334 acan implement cloud computing capabilities for analyte sensor system 308and/or display devices 310.

FIG. 3B depicts system 302, which includes examples of additionalaspects of the present disclosure that can be used in connectionimplementing an analyte sensor system. As illustrated in FIG. 3B, system302 can include analyte sensor system 308. As shown, analyte sensorsystem 308 can include analyte sensor 375 (e.g., which can also bedesignated with the numeral 10 in FIG. 1A) coupled to sensor measurementcircuitry 370 for processing and managing sensor data. Sensormeasurement circuitry 370 can be coupled to processor/microprocessor 380(e.g., which can be part of the sensor electronics module 12 in FIG.1A). In some embodiments, processor 380 can perform part or all of thefunctions of the sensor measurement circuitry 370 for obtaining andprocessing sensor measurement values from sensor 375. Processor 380 canbe further coupled to a radio unit or transceiver 360 (e.g., which canbe part of the sensor electronics module 12 in FIG. 1A) for sendingsensor data and receiving requests, commands and/or temporary power froman external device, such as display device 310, which can be used todisplay or otherwise provide the sensor data (or analyte data) to auser. As used herein, the terms “radio,” “radio unit,” “transceiver,”“radio transceiver” and “transceiver radio” are used interchangeably andgenerally refer to a device, circuitry or module that can wirelesslytransmit and receive data. In addition, according to some embodiments,transceiver 360 can further comprise an NFC antenna and associatedcircuitry configured to receive power from another device, e.g., displaydevice 310, via a near field communication, which analyte sensor system308 can utilized to temporarily power one or more of its componentsnecessary for communicating with another device, for example, in caseswhere an internal battery of analyte sensor system 308 (not shown) hasinsufficient power or is otherwise unable to adequately power suchcomponents. Analyte sensor system 308 can further include storage 365(e.g., which can be part of the sensor electronics module 12 in FIG. 1A)and real time clock (RTC) 380 (e.g., which can be part of the sensorelectronics module 12 in FIG. 1A) for storing and tracking sensor data.

As alluded to above, wireless communication protocols can be used totransmit and receive data between analyte sensor system 308 and thedisplay device 310 via communication medium 305. Such wireless protocolscan be designed for use in a wireless network that is optimized forperiodic and small data transmissions (that can be transmitted at lowrates if necessary) to and from multiple devices in a close range (e.g.,a personal area network (PAN)). For example, one such protocol can beoptimized for periodic data transfers where transceivers can beconfigured to transmit data for short intervals and then enter low powermodes for long intervals. The protocol can have low overheadrequirements both for normal data transmissions and for initiallysetting up communication channels (e.g., by reducing overhead) to reducepower consumption. In some embodiments, burst broadcasting schemes(e.g., one-way communication) can be used. This can eliminate overheadrequired for acknowledgement signals and allow for periodictransmissions that consume little power. In other embodiments, passiveor active proximity-based protocols can be employed to reduce overhead(e.g., overhead associated with typical pairing operations) and/orincrease security, with NFC being one specific example.

The protocols can further be configured to establish communicationchannels with multiple devices while implementing interference avoidanceschemes. In some embodiments, the protocol can make use of adaptiveisochronous network topologies that define various time slots andfrequency bands for communication with several devices. The protocol canthus modify transmission windows and frequencies in response tointerference and to support communication with multiple devices.Accordingly, the wireless protocol can use time and frequency divisionmultiplexing (TDMA) based schemes. The wireless protocol can also employdirect sequence spread spectrum (DSSS) and frequency-hopping spreadspectrum schemes. Various network topologies can be used to supportshort-distance and/or low-power wireless communication such aspeer-to-peer, start, tree, or mesh network topologies such as Wi-Fi,Bluetooth and Bluetooth Low Energy (BLE). The wireless protocol canoperate in various frequency bands such as an open ISM band such as 2.4GHz. Furthermore, to reduce power usage, the wireless protocol canadaptively configure data rates according to power consumption.

With further reference to FIG. 3B, system 302 can include display device310 communicatively coupled to analyte sensor system 308 viacommunication medium 305. In the illustrated embodiment, display device310 includes connectivity interface 315 (which in turn includestransceiver 320), storage 325 (which in turn stores analyte sensorapplication 330 and/or additional applications),processor/microprocessor 335, graphical user interface (GUI) 340 thatcan be presented using display 345 of display device 310, and real timeclock (RTC) 350. A bus (not shown here) can be used to interconnect thevarious elements of display device 310 and transfer data between theseelements.

Display device 310 can be used for alerting and providing sensorinformation or analyte data to a user and can include aprocessor/microprocessor 335 for processing and managing sensor data.Display device 310 can include display 345, storage 325, analyte sensorapplication 330, and real time clock 350 for displaying, storing, andtracking sensor data. Display device 310 can further include a radiounit or transceiver 320 coupled to other elements of display device 310via connectivity interface 315 and/or a bus. Transceiver 320 can be usedfor receiving sensor data and for sending requests, instructions, data,and/or power to analyte sensor system 308. Transceiver 320 can furtheremploy a communication protocol. Storage 325 can also be used forstoring an operating system for display device 310 and/or a custom(e.g., proprietary) application designed for wireless data communicationbetween a transceiver and display device 310. Storage 325 can be asingle memory device or multiple memory devices and can be a volatile ornon-volatile memory for storing data and/or instructions for softwareprograms and applications. The instructions can be executed by processor335 to control and manage transceiver 320.

In some embodiments, when a standardized communication protocol is used,commercially available transceiver circuits can be utilized thatincorporate processing circuitry to handle low level data communicationfunctions such as the management of data encoding, transmissionfrequencies, handshake protocols, and the like. In these embodiments,processor 335, 380 does not need to manage these activities, but ratherprovides desired data values for transmission, and manages high levelfunctions such as power up or down, set a rate at which messages aretransmitted, and the like. Instructions and data values for performingthese high-level functions can be provided to the transceiver circuitsvia a data bus and transfer protocol established by the manufacturer ofthe transceiver 320, 360.

Components of analyte sensor system 308 can require replacementperiodically. For example, analyte sensor system 308 can include animplantable sensor 375 that can be attached to a sensor electronicsmodule, e.g., sensor electronics module 12, that includes sensormeasurement circuitry 370, processor 380, storage 365, and transceiver360, and a battery (not shown). Sensor 375 can require periodicreplacement (e.g., every 7 to 30 days). The sensor electronics modulecan be configured to be powered and active for much longer than sensor375 (e.g., for three to six months or more) until the battery needsreplacement. Replacing these components can be difficult and require theassistance of trained personnel. Reducing the need to replace suchcomponents, particularly the battery, significantly improves theconvenience and cost of using analyte sensor system 308, including tothe user. In some embodiments, when a sensor electronic module is usedfor the first time (or reactivated once a battery has been replaced insome cases), it can be connected to sensor 375 and a sensor session canbe established. As will be further described below, there can be aprocess for initially establishing communication between display device310 and the sensor electronics module, e.g., sensor electronics module12, when the module is first used or re-activated (e.g., the battery isreplaced). Once display device 310 and sensor electronics module haveestablished communication, display device 310 and the sensor electronicsmodule can periodically and/or continuously be in communication over thelife of several sensors 375 until, for example, the battery needs to bereplaced. Each time sensor 375 is replaced, a new sensor session can beestablished. The new sensor session can be initiated through a processcompleted using display device 310 and the process can be triggered bynotifications of a new sensor via the communication between the sensorelectronics module and display device 310 that can be persistent acrosssensor sessions.

Analyte sensor system 308 typically gathers analyte data from sensor 375and transmits the same to display device 310. Data points regardinganalyte values can be gathered and transmitted over the life of sensor375 (e.g., in the range of 1 to 30 days or more). New measurements canbe transmitted often enough to adequately monitor glucose levels. Ratherthan having the transmission and receiving circuitry of each of analytesensor system 308 and display device 310 continuously communicating,analyte sensor system 308 and display device 310 can regularly and/orperiodically establish a communication channel between them. Thus,analyte sensor system 308 can in some cases communicate via wirelesstransmission with display device 310 (e.g., a hand-held computingdevice, medical device, or proprietary device) at predetermined timeintervals. The duration of the predetermined time interval can beselected to be long enough so that analyte sensor system 308 does notconsume too much power by transmitting data more frequently than needed,yet frequent enough to provide substantially real-time sensorinformation (e.g., measured glucose values or analyte data) to displaydevice 310 for output (e.g., via display 345) to a user. While thepredetermined time interval is every five minutes in some embodiments,it is appreciated that this time interval can be varied to be anydesired length of time.

With continued reference to FIG. 3B, as shown, connectivity interface315 interfaces display device 310 to communication medium 305, such thatdisplay device 310 can be communicatively coupled to analyte sensorsystem 308 via communication medium 305. Transceiver 320 of connectivityinterface 315 can include multiple transceiver modules and/or circuitryoperable on different wireless standards. Transceiver 320 can be used toreceive analyte data and associated commands and messages from analytesensor system 308. In some embodiments, transceiver 320 can comprise anear field communication (NFC) controller configured to transmit an NFCsignal for communicating with and/or temporarily providing power toanother device, for example, analyte sensor system 308, as will bedescribed in more detail in connection with one or more embodimentsbelow. Additionally, connectivity interface 315 can in some casesinclude additional components for controlling radio and/or wiredconnections, such as baseband and/or Ethernet modems, audio/videocodecs, BLE, Bluetooth, and/or cellular connections and so on.

Storage 325 can include volatile memory (e.g. RAM) and/or non-volatilememory (e.g. flash storage), can include any of EPROM, EEPROM, cache, orcan include some combination/variation thereof. In various embodiments,storage 325 can store user input data and/or other data collected bydisplay device 310 (e.g., input from other users gathered via analytesensor application 330). Storage 325 can also be used to store volumesof analyte data received from analyte sensor system 308 for laterretrieval and use, e.g., for determining trends and triggering alerts.Additionally, storage 325 can store analyte sensor application 330 that,when executed using processor 335, for example, receives input (e.g., bya conventional hard/soft key or a touch screen, voice detection, orother input mechanism), and allows a user to interact with the analytedata and related content via GUI 340, as will be described in furtherdetail herein.

In various embodiments, a user can interact with analyte sensorapplication 330 via GUI 340, which can be provided by display 345 ofdisplay device 310. By way of example, display 345 can be a touchscreendisplay that accepts various hand gestures as inputs. Application 330can process and/or present analyte-related data received by displaydevice 310, according to various operations described herein, andpresent such data via display 345. Additionally, application 330 can beused to obtain, access, display, control, and/or interface with analytedata and related messaging and processes associated with analyte sensorsystem 308, as is described in further detail herein.

Application 330 can be downloaded, installed, and initiallyconfigured/setup on display device 310. For example, display device 310can obtain application 330 from server system 334, or from anothersource accessed via a communication medium (e.g., communication medium305), such as an application store or the like. Following installationand setup, application 330 can be used to access and/or interface withanalyte data (e.g., whether stored on server system 334, locally fromstorage 325, or from analyte sensor system 308). By way of illustration,application 330 can present a menu that includes various controls orcommands that can be executed in connection with the operating ofanalyte sensor system 308 and one or more display devices 310.Application 330 can also be used to interface with or control otherdisplay devices 310, for example, to deliver or make available theretoanalyte data, including for example by receiving/sending analyte datadirectly to the other display device 310 and/or by sending aninstruction for analyte sensor system 308 and the other display device310 to be connected, etc., as will be described herein. Additionally,application 330 in some implementations can interact with one or moreadditional applications supported by display device 310, for example toretrieve or supply relevant data. Such applications can include, by wayof example, fitness/lifestyle monitoring applications, social mediaapplications, and so on.

Analyte sensor application 330 can include various code/functionalmodules, such as, for example, a display module, a menu module, a listmodule, and so on as will become clear in light of the description ofvarious functionalities herein (e.g., in connection with disclosedmethods). These modules can be implemented separately or in combination.Each module can include computer-readable media and havecomputer-executable code stored thereon, such that the code can beoperatively coupled to and/or executed by processor 335 (which, e.g.,can include a circuitry for such execution) to perform specificfunctions (e.g., as described herein with regard to various operationsand flow charts etc.) with respect to interfacing with analyte data andperforming tasks related thereto. As will be further described below, adisplay module can present (e.g., via display 345) various screens to auser, with the screens containing graphical representations ofinformation provided by application 330. In further embodiments,application 330 can be used to display to the user an environment forviewing and interacting with various display devices that can beconnectable to analyte sensor system 308, as well as with analyte sensorsystem 308 itself. Sensor application 330 can include a nativeapplication modified with a software design kit (e.g., depending on theoperating system) in order to carry out the functionalities/featuresdescribed herein.

Referring again to FIG. 3B, display device 310 also includesprocessor/microcontroller 335. Processor 335 can include processorsub-modules, including, by way of example, an applications processorthat interfaces with and/or controls other elements of display device310 (e.g., connectivity interface 315, application 330, GUI 340, display345, RTC 350, etc.). Processor 335 can include a controller and/ormicrocontroller that provides various controls (e.g., interfaces withbuttons and switches) related to device management, such as, forexample, lists of available or previously paired devices, informationrelated to measurement values, information related to network conditions(e.g., link quality and the like), information related to the timing,type, and/or structure of messaging exchanged between analyte sensorsystem 308 and display device 310, and so on. Additionally, thecontroller can include various controls related to the gathering of userinput, such as, for example, a user's finger print (e.g., to authorizethe user's access to data or to be used for authorization/encryption ofdata, including analyte data), as well as analyte data.

Processor 335 can include circuitry such as logic circuits, memory, abattery and power circuitry, and other circuitry drivers for peripherycomponents and audio components. Processor 335 and any sub-processorsthereof can include logic circuits for receiving, processing, and/orstoring data received and/or input to display device 310, and data to betransmitted or delivered by display device 310. Processor 335 can becoupled by a bus to display 345 as well as connectivity interface 315and storage 325 (including application 330). Hence, processor 335 canreceive and process electrical signals generated by these respectiveelements and thus perform various functions. By way of example,processor 335 can access stored content from storage 325 at thedirection of application 330 and process the stored content for displayand/or output by display 345. Additionally, processor 335 can processthe stored content for transmission via connectivity interface 315 andcommunication medium 305 to other display devices 310, analyte sensorsystem 308, or server system 334. Display device 310 can include otherperipheral components not shown in detail in FIG. 3B.

In further embodiments, processor 335 can further obtain, detect,calculate, and/or store data input by a user via display 345 or GUI 340,or data received from analyte sensor system 308 (e.g., analyte sensordata or related messaging), over a period of time. Processor 335 can usethis input to gauge the user's physical and/or mental response to thedata and/or other factors (e.g., time of day, location, etc.). Invarious embodiments, the user's response or other factors can indicatepreferences with respect to the use of certain display devices 310 undercertain conditions, and/or the use of certain connection/transmissionschemes under various conditions, as will be described in further detailherein.

It should be noted at this juncture that like-named elements as betweendisplay device 310 and analyte sensor system 308 can include similarfeatures, structures, and/or capabilities. Therefore, with respect tosuch elements, the description of display device 310 above can in somecases be applied to analyte sensor system 308.

Turning now to FIG. 3C, system 304 is depicted in accordance withembodiments of the present disclosure. As shown, system 304 includesanalyte sensor system 308 communicatively coupled with display devices310 a, 310 b via communication medium 305 a. Display device 310 a isalso communicatively coupled to display device 310 b via communicationmedium 305 b. By way of example, FIG. 3C illustrates that in exampleimplementations of the disclosure, display device 310 a can connect toanalyte sensor system 308 using a first connection scheme and a firstwireless protocol (e.g., BLE or any other preferred communicationprotocol and/or scheme). In embodiments, display device 310 b can alsoconnect to analyte sensor system 308 using the first connection schemeand first wireless protocol (e.g., BLE) and/or utilizing a secondconnection scheme and a second wireless protocol different from thefirst connection scheme and first wireless protocol. In turn, displaydevice 310 a can also connect to display device 310 b using any one ofthe first connection scheme and first wireless protocol, the secondconnection scheme and second wireless protocol and/or a third connectionscheme and a third wireless protocol (e.g., Wi-Fi, NFC, etc.). Further,for example, display devices 310 a and 310 b can exchange analyte datawith one another via communication medium 305 b, where each displaydevice 310 a, 310 b received the analyte data via communication medium305 a, that is, from analyte sensor system 308. Additional aspects andfeatures represented by FIG. 3C will become apparent upon studying theentirety of the present disclosure.

Factory Calibration and Testing

Before a user can utilize analyte sensor system 308, it can first beprogrammed and/or factory calibrated with sensor calibration data. Suchprogramming can include at least the loading of sensor calibration datafor sensor 375 and/or sensor measurement circuitry 370 (FIG. 3B) ontostorage 365 so that sensor measurement circuitry 370 can accuratelymeasure, estimate or otherwise determine an analyte concentration for auser based on a signal from sensor 375. However, because suchprogramming must be performed for many analyte sensor systems, in somecases thousands of units or more, it is desirable to streamline theprogramming and/or factory calibration process as much as practical.Accordingly, some embodiments described below provide streamlinedfactory calibration of sensor 375 and/or sensor measurement circuitry370 by minimizing an amount of communication required to initiate andvalidate a connection between a factory calibration system and analytesensor system 308 and by minimizing an amount of communication utilizedwhile performing the factory calibration.

FIG. 3D illustrates aspects of an example factory calibration system 399that can be used in connection with implementing embodiments of thedisclosure. System 399 can comprise one or more of a factory calibrationstation 381, a sensor calibration database 392, a server 391 and ananalyte sensor kit box 398. Several components of factory calibrationstation 381, sensor calibration database 392, server 391 and analytesensor kit box 398 will be described below. However, it should beunderstood that factory calibration station 381, sensor calibrationdatabase 392, server 391 and analyte sensor kit box 398 can comprisemore, fewer or different components than those discussed.

In some embodiments, analyte sensor system 308 can be packaged alongwith at least an applicator (not shown) within analyte sensor kit box398. An identification tag 397 (e.g., a barcode, QR code or the like)can be disposed on analyte sensor system 308, the applicator, analytesensor kit box 398, or at any location such that identification tag 397is readily accessible by factory calibration station 381, e.g., withoutaltering, opening or unpacking analyte sensor kit box 398.Identification tag 397 can be encoded to identify the specific sensor375 disposed within analyte sensor system 308. For example, in someembodiments, identification tag 397 can be encoded with at least anapplicator lot number corresponding to the applicator disposed withinanalyte sensor kit box 398 and a sensor serial number corresponding tosensor 375 disposed within analyte sensor system 308, as will bedescribed in more detail below.

Factory calibration station 381 can comprise a processor 386 and amemory 387 configured to communicate with one or more other componentsof factory calibration station 381, server 391, sensor calibrationdatabase 392 and/or analyte sensor system 308. In some embodiments,memory 387 can have loaded thereon non-transitory computer-readableinstructions that, when executed by processor 386, enable functionalityat least as described in this disclosure.

Factory calibration station 381 can comprise a load sensor 382configured to sense when analyte sensor kit box 398 is properlypositioned on or near factory calibration station 381 for factorycalibration of analyte sensor system 308. In some embodiments, loadsensor 382 can comprise a scale and proper positioning of analyte sensorkit box 398 can be sensed based on load sensor 382 generating a signalindicating a load on load sensor 382 that can correspond to analytesensor kit box 398.

Factory calibration station 381 can further comprise a identificationtag scanner 383 configured to read identification tag 397. Theinformation encoded in identification tag 397 can then be utilized byfactory calibration station 381 to retrieve the unique sensorcalibration data for sensor 375 from sensor calibration database 392. Insome embodiments, sensor calibration data for a plurality of sensorsincluding sensor 375 can be stored in sensor calibration database 392 inthe form of a .CSV lookup table. However, the present disclosure is notso limited, and the sensor calibration data can be stored in any form.

Factory calibration station 381 can further comprise a short-rangecommunications controller 384 configured to communicate with transmitter360 (which can include a short-range antenna and associated circuitry)to thereby wake, e.g., transition to an operational mode, one or morecomponents of analyte sensor system 308 when analyte sensor system 308is brought into sufficiently close proximity to controller 384. In someembodiments, controller 384 may comprise a near-field communication(NFC) controller. Controller 384 can then transfer at least a portion ofthe sensor calibration data for sensor 375 retrieved from sensorcalibration database 392 to analyte sensor system 308, via transmitter360. The transferred sensor calibration data can be written and/orstored in one or more locations within storage 365 of analyte sensorsystem 308. In some embodiments, since NFC communication protocols areutilized, the sensor calibration data can be written to the one or morelocations within storage 365 utilizing a single NFC command (e.g.,0x7A—get sensor parameters), thereby eliminating or at leastsubstantially reducing the use of other time-consuming pairing andauthenticating protocols during at least this phase of factorycalibration.

Factory calibration station 381 can further comprise one or more labelprinters 388 configured to print one or more labels indicating dataassociated with the factory calibration process for analyte sensorsystem 308.

Factory calibration station 381 can be further configured to generateand/or communicate information regarding the factory calibration processfor analyte sensor system 308 to server 391, which can be configured togenerate and/or transmit one or more summary reports related to thefactory calibration process of one or more analyte sensor systems.

Some embodiments describe examples of encoding of the informationprovided by identification tag 397 below. Identification tag 397 can bea 2-dimensional barcode encoding an applicator lot number correspondingto analyte sensory kit box 398 and a sensor serial number correspondingto sensor 375 of analyte sensor system 308 in a single string.Accordingly, upon scanning identification tag 397, identification tagscanner 383 can be configured to retrieve the applicator lot number andthe sensor serial number in a single string. An example is describedbelow for illustrative purposes only.

In some embodiments, the applicator lot number can comprise a string ofnumbers without letters and can be stored as an unsigned 32-bit number(U32). Utilization of U32 provides 2³² (4,294,967,296) possible uniqueapplicator lot numbers. An example of such an applicator lot number canbe 151110428. In other embodiments, the applicator lot number cancomprise another combination of numbers, letters and/or other symbols.

In some embodiments, the sensor serial number can comprise an 8-digitportion of the sensor's Universal Fixture serial number and a character(e.g., A-H) indicating a starting position within the full UniversalFixture serial number at which the 8-digit sensor serial number begins.The 8-digit sensor Universal Fixture serial number and the character canbe encoded together in an unsigned 32-bit number (u32), wherein theleast significant 24 bits (LSB) of the U32 specify the 8-digit sensorserial number and the most significant 8 bits (MSB) of the U32 specifythe universal fixture position-indicating character, for example, inASCII format. An example of such a sensor serial number can be 700958B.In other embodiments, the sensor serial number can comprise anothercombination of numbers, letters and/or other symbols.

Thus, utilizing the above example applicator lot number and sensorserial number, barcode 397 can be configured to encode the followingsingle string: 151110428700958B, where bold and underlines are used forclarity purposes only. When scanned by identification tag scanner 383,identification tag 397 would then provide the following three pieces ofinformation: [Applicator Lot Number] [6-digit Serial Number] [UniversalFixture Position Character] as [151110428] [700958] [B], where theapplicator lot number 151110428 is directly encoded as a U32, the sensoruniversal fixture serial number and position are separately encoded as700958 decimal=0x0AB21E hex and ASCII “B”=86 decimal=0x42 hex, and thenrecombined and/or concatenated (MSB to LSB), indicated in U32 as:[8][24]=[ASCII B=86][700958]=1107997214 (66*2²⁴+700958); and indicatedin Hex as: [8][24]=[0x42][0x0A][0xB2][0x1E]=0x420AB21E.

An example use of the single 0x7A NFC command for transmitting sensorcalibration data from factory calibration station 381 to analyte sensorsystem 308, utilizing NFC controller 384 and an NFC antenna and/ortransmitter circuitry within transmitter 360, respectively, will now bedescribed.

In some embodiments, factory calibration station 381 can cause thesensor calibration data to be written to storage 365 of analyte sensorsystem 308 utilizing a single NFC command 0x7A, where the sensorcalibration data comprises the following parameters: an initial slope(m0) of sensor 375, a final slope (mf) of sensor 375, an applicator lotnumber associated with analyte sensor kit box 398, e.g., as describedabove, a sensor serial number for sensor 375, e.g., as described above,and a sensor calibration check date (cc). This sensor calibration datacan be transmitted to analyte sensor system 308 in 20 bytes, as providedby the NFC command 0x7A, according to the following table.

TABLE 1 Factory Transmitter Opcode 0x7A Calibration Station storage 365Byte Definition 381 Definition location 0-3 Sensor m0 (float) SensorInitial Slope Transmitter Database m0 (float) 4-7 Sensor mf (float)Sensor Final Slope Transmitter Database mf (float)  8-11 Sensor DataApplicator Lot No. UICR Memory (u32) (rewritable) 12-15 Sensor SerialNo. UICR Memory (u32) (rewritable) 16-19 Sensor CalCheck UICR MemoryDate (u32) (rewritable)

Sensor initial slope (m0) can be read from sensor calibration database392, for example, indexed by the applicator lot number and sensor serialnumber read from identification tag 397. Sensor initial slope (m0) canhave units of picoamperes per milligram per deciliter (pA/mg/dL) and canbe programmed in a transmitter database within storage 365 via command0x7A as a floating-point number (float) using 4 bytes (bytes 0-3), insome embodiments without encoding. Once written, this value isnon-volatile and can remain in the transmitter database of storage 365until rewritten or until the transmitter database is erased.

Sensor final slope (mf) can be read from sensor calibration database392, for example, indexed by the applicator lot number and sensor serialnumber read from identification tag 397. Sensor final slope (mf) canhave units of pA/mg/dL and can be programmed in the transmitter databasewithin storage 365 via command 0x7A as a floating-point number (float)using 4 bytes (bytes 4-7), in some embodiments without encoding. Oncewritten, this value is non-volatile and will remain in the transmitterdatabase of storage 365 until rewritten or until the transmitterdatabase is erased.

As previously described, the applicator lot number can have been encodedin identification tag 397 and can be programmed in user informationconfiguration registers (UICR) memory within storage 365 via command0x7A as an unsigned 32-bit number (u32) using 4 bytes (bytes 8-11), aspreviously encoded. Once written, this value is non-volatile and canremain in the transmitter UICR memory of storage 365 until rewritten oruntil the transmitter UICR memory is erased or reflashed.

As previously described, the sensor serial number may have been encodedin identification tag 397 and can be programmed in the user informationconfiguration registers (UICR) memory within storage 365 via command0x7A as an unsigned 32-bit number (u32) using 4 bytes (bytes 12-15), aspreviously encoded. Once written, this value is non-volatile and canremain in the transmitter UICR memory of storage 365 until rewritten oruntil the transmitter UICR memory is erased or reflashed.

Sensor calibration Check date (cc) can be read from sensor calibrationdatabase 392, for example, indexed by the applicator lot number andsensor serial number read from identification tag 397. Sensor calcheckdate (cc) can be the UTC timestamp at which the sensor CalCheck wasperformed and can be programmed in the user information configurationregisters (UICR) memory within storage 365 via command 0x7A as anunsigned 32-bit number (u32) using 4 bytes (bytes 16-19), as previouslyencoded. Once written, this value is non-volatile and can remain in thetransmitter UICR memory of storage 365 until rewritten or until thetransmitter UICR memory is erased or reflashed.

A method 500 for calibrating an analyte sensor directed to theabove-described factory calibration (e.g., FIG. 3D) will now bedescribed in connection with FIG. 5 below.

At operation 502, method 500 includes scanning an identification tagencoding information identifying an analyte sensor. For example, factorycalibration station 381 can scan identification tag 397 of analytesensor kit box 398, utilizing identification tag scanner 383. Aspreviously described, identification tag 397 can be a 2-dimensional (2D)barcode encoding at least an applicator lot number and a sensor serialnumber corresponding to analyte sensor system in a single string.

At operation 504, method 500 includes retrieving sensor calibration databased at least in part on the information identifying the analytesensor. For example, factory calibration station 381 can retrieve sensorcalibration data specifically corresponding to sensor 375 from sensorcalibration database 392. Sensor calibration data can include theinitial slope (m0) determined for sensor 375, the final slope (mf)determined for sensor 375 and the date (cc) on which the testingprocedure that determined the initial and final slopes of sensor 275 wasperformed. As previously described, in some embodiments, the initialslope (m0), final slope (mf) and date (cc) for sensor 375 can be indexedin sensor calibration database 392 based on the applicator lot numberand sensor serial number corresponding to sensor 375.

At operation 506, method 500 includes disposing the analyte sensorsystem sufficiently close to the factory calibration station for ashort-range communication controller of the factory calibration stationto induce a short-range antenna within analyte sensor system to cause atleast a portion of analyte sensor system to transition to an operationalmode. For example, moving analyte sensor kit box 398 within apredetermined distance (e.g., 10 cm) of factory calibration station 381can allow a near field communication signal transmitted by NFCcontroller 384 to induce an NFC antenna within transmitter 360 ofanalyte sensor system 308 to generate a signal configured to wake atleast one of connectivity interface 355, storage 365, sensor measurementcircuitry 370, sensor 375, processor 380 and/or real time clock 385 inpreparation for receiving sensor calibration data.

At operation 508, method 500 includes transferring at least the sensorcalibration data to the analyte sensor system via short-rangecommunications responsive to a command, thereby facilitating calibrationof the continuous analyte sensor system. For example, utilizing NFC,factory calibration station 381 can utilize a single 0x7A NFC command totransfer the initial slope (m0), final slope (mf), testing proceduredate (cc), applicator lot number and sensor serial number to analytesensor system 308. This sensor calibration data can be stored in one ormore memory locations within analyte sensor system 308, for example,storage 365.

In some embodiments, at operation 510, method 500 can further includecausing the analyte sensor system to revert to a sleep mode after thesensor calibration data is stored in a storage of the analyte sensorsystem. For example, in some embodiments factory calibration station 381can be configured to further send a sleep command to analyte sensorsystem 308, for example via NFC controller 384, upon receipt of aconfirmation from analyte sensor system 308 that the 0x7A command wassuccessfully completed. In some other embodiments, analyte sensor system308 can be configured to automatically revert to the sleep mode afterthe sensor calibration data is stored in the one or more locationswithin storage 365. Reversion to sleep mode upon storage of the sensorcalibration data can minimize or at least substantially reduce powerusage of analyte sensor system 308 during and after the factorycalibration process, thereby extending useful battery life duringsubsequent use by a patient.

Turning to FIG. 3E, in addition to factory calibration, analyte sensorsystem 308 can be tested to ensure anticipated operation. Such testingcan include communication between a factory testing station 351 andanalyte sensor system 308. However, such communication can includeadvertising, connecting and authenticating processes that take placebefore any meaningful testing communication is carried out, making for atime-efficient communication process. This problem is compounded whensuch testing protocols include writing to user information configurationregisters (UICRs) within storage 365 of analyte sensor system 308, forexample, since such writes can cause analyte sensor system 308 toreboot, which causes the advertising, connecting and authenticatingprocesses to be repeated. In addition, some testing protocols canrequire communication with connectivity interface 355 and/or transmitter360 of analyte sensor system 308 directly, at least for conducting sometypes of field failure analyses. Because such testing can be performedfor many analyte sensor systems, in some cases thousands of units ormore, it is desirable to streamline the factory testing process.Accordingly, some embodiments described below provide streamlinedfactory testing of analyte sensor system 308 that avoids theadvertising, connecting and authenticating processes at least duringportions of such factory testing.

System 359, shown in FIG. 3E, can comprise a factory testing station 351and analyte sensor system 308. In some embodiments, analyte sensorsystem 308 can be disposed in analyte sensor kit box 398 as previouslydescribed in connection with FIG. 3D. However, the present disclosure isnot so limited and analyte sensor system 308 can be tested while outsideof analyte sensor kit box 398. In some embodiments, system 359 canadditionally comprise an analyte sensor system testing database 357,which can store thereon instructions and/or data that can be retrieved,stored and/or used before, during and/or after one or more factorytesting protocols for analyte sensor system 308.

Several components of factory testing station 351, analyte sensor systemtesting database 357, and analyte sensor system 308 will be describedbelow. However, it should be understood that factory testing station351, analyte sensor system testing database 357, and analyte sensorsystem 308 can comprise more, fewer or different components than thosediscussed.

In the illustrated embodiment, factory testing station 351 includesconnectivity interface 352 (which in turn includes transceiver 353),storage 354 (which in turn stores one or more testing programs 356and/or additional applications), processor/microprocessor 357, real timeclock (RTC) 361, and in some cases, a display 359 and a graphical userinterface (GUI) 358 that can be presented thereon. A bus (not shownhere) can be used to interconnect the various elements of factorytesting station 351 and transfer data between these elements.

Storage 354 can also be used for storing an operating system for factorytesting station 351 and/or a custom (e.g., proprietary) applicationdesigned for wireless data communication between transceiver 360 ofanalyte sensory system 308 and transceiver 353 of factory testingstation 351. Storage 354 can be a single memory device or multiplememory devices and can be a volatile or non-volatile memory for storingdata and/or instructions for software programs and applications. Theinstructions can be executed by processor 357 to control and manage atesting process.

To facilitate prompt wireless communication between factory testingstation 351 and analyte sensor system 308, each of transceiver 353 (offactory testing station 351) and transceiver 360 (of analyte sensorsystem 308) can comprise identical or substantially similarly designedand/or programmed radio chips (e.g., Nordic chips). Utilizing identicalor substantially similarly designed and/or programmed radio chipsfacilitate point-to-point wireless communication between factory testingstation 351 and analyte sensor system 308 without using a commerciallystandardized communication protocol stack, such as BLE. For example, oneor more of transceiver 353, connectivity interface 352 and storage 354,and one or more of transceiver 360, connectivity interface 355, andstorage 365 can each comprise firmware configured to cause transceivers353, 360 to send and receive raw packets of data between one anotherduring the factory testing process, which can allow such testingprocesses to be completed an order of magnitude faster than if astandardized communication protocol, such as BLE and its associated BLEstack, were utilized. Such non-standardized communication can befacilitated by appropriately configuring one or more registers ontransceivers 353, 360 directly, without enabling, for example, a BLEstack.

In such embodiments, transceivers 353, 360 can each be preconfiguredand/or preprogrammed to communicate (e.g., transmit and/or receive oneor more signals) with one another on a same, programmed frequency (e.g.,channel) during the testing process. Such preconfiguring eliminates anyrequirement for negotiating channel selection between transceivers 353,360. For example, upon waking from a sleep mode, transceiver 360 ofanalyte sensor system 308 monitors a predetermined frequency channel fora data packet of a predetermined size and format. In suchimplementations, factory testing station 351 can be the “master” andanalyte sensor system 308 can be the “slave” during the testing process.Transceiver 353 is configured to transmit and transceiver 360 isconfigured to receive a data packet comprising a request (e.g., anopcode) for analyte sensor system 308 to perform one or more tasks orprocedures designed to verify anticipated operation of analyte sensorsystem 308. Upon receipt of the request packet, one or more oftransceiver 360, connectivity interface 355, and processor 380 canprocess the request. Transceiver 360 then transmits and transceiver 353receives a response returning a result of the request. Upon completionof the testing procedure, transceiver 353 transmits and transceiver 360receives a message instructing one or more components of analyte sensorsystem 308 to revert to a sleep mode. In some embodiments, such amessage can comprise an “all complete” opcode.

In some embodiments, packet transmission failures and/or collisions canbe mitigated by utilizing conventional timeouts and retries. In someembodiments, multiple testing stations can be provided to operateconcurrently through the utilization of RF shielding surrounding eachtesting station comprising a factory testing station and an analytesensor system under test as described above. In some other embodiments,multiple testing stations can be provided to operate concurrently bypre-configuring and/or preprogramming each analyte sensor system undertest to utilize a unique one of a plurality of available frequencies(e.g., channels) for the testing process. In such embodiments, eachfactory testing station can be configured to sync with or track theparticular analyte sensor system(s) being pre-configured and/orpreprogrammed to utilize the same frequency during the testing process(e.g., a kHz, MHz or GHz frequency or any frequency suitable forradio-frequency communications).

A flowchart 600 for testing an analyte sensor system directed to theabove-described factory testing (e.g., FIG. 3E) will now be described inconnection with FIG. 6A below. Flowchart 600 can correspond tooperations of analyte sensor system 308.

At operation 602, flowchart 600 includes waking at least a portion of ananalyte sensor system from a sleep mode. For example, analyte sensorsystem 308 can be configured to wake from a power-saving shelf- orsleep-mode in response to an initiation of a testing procedure.

At operation 604, flowchart 600 includes receiving, utilizing a firsttransceiver chip, a data packet transmitted from a second transceiverchip, the data packet comprising a request for the analyte sensor systemto perform one or more tasks designed to verify anticipated operation ofthe analyte sensor system. For example, transceiver 353 of factorytesting station 351 is configured to transmit and transceiver 360 ofanalyte sensor system 308 is configured to receive a data packetcomprising a request (e.g., an opcode) for analyte sensor system 308 toperform one or more tasks or procedures designed to verify anticipatedoperation of analyte sensor system 308. Transceivers 353, 360 cancomprise identical or substantially similar transceiver chips (e.g.,Nordic chips).

At operation 606, flowchart 600 includes processing the request. Forexample, upon receipt of the request packet, one or more of transceiver360, connectivity interface 355, and processor 380 of analyte sensorsystem 308 can process the request.

At operation 608, flowchart 600 includes transmitting, utilizing thefirst transceiver chip, a response returning a result of the request tothe second transceiver chip. For example, transceiver 360 of analytesensor system 308 can transmit and transceiver 353 of factory testingstation 351 can receive a response returning a result of the request.

At operation 610, flowchart 600 includes receiving, utilizing the firsttransceiver chip, a message transmitted from the second transceiverchip, the message comprising instructions that cause one or morecomponents of the analyte sensor system to revert to a sleep mode. Forexample, transceiver 353 of factory testing station 351 can transmit andtransceiver 360 of analyte sensor system 308 can receive a messagecomprising instructions that cause one or more components of analytesensor system 308 to revert to a sleep mode. In some embodiments, such amessage can comprise an “all complete” opcode.

A flowchart 650 for testing an analyte sensor system directed to theabove-described factory testing (e.g., FIG. 3E) will now be described inconnection with FIG. 6A below. Flowchart 650 can correspond tooperations of factory testing station 351.

At operation 652, flowchart 650 includes transmitting to a firsttransceiver chip, utilizing a second transceiver chip, a data packetcomprising a request for the analyte sensor system to perform one ormore tasks designed to verify anticipated operation of the analytesensor system. For example, transceiver 353 of factory testing station351 is configured to transmit and transceiver 360 of analyte sensorsystem 308 is configured to receive a data packet comprising a request(e.g., an opcode) for analyte sensor system 308 to perform one or moretasks or procedures designed to verify anticipated operation of analytesensor system 308. Transceivers 353, 360 can comprise identical orsubstantially similar transceiver chips.

At operation 654, flowchart 650 includes receiving, utilizing the secondtransceiver chip, a response returning a result of the request from thefirst transceiver chip. For example, transceiver 360 of analyte sensorsystem 308 can transmit and transceiver 353 of factory testing station351 can receive a response returning a result of the request.

At operation 656, flowchart 650 includes transmitting, utilizing thesecond transceiver chip, a message to the first transceiver chip, themessage comprising instructions that cause one or more components of theanalyte sensor system to revert to a sleep mode. For example,transceiver 353 of factory testing station 351 can transmit andtransceiver 360 of analyte sensor system 308 can receive a messagecomprising instructions that cause one or more components of analytesensor system 308 to revert to a sleep mode. In some embodiments, such amessage can comprise an “all complete” opcode.

Analyte Sensor System Low-Power, Sleep and/or Shelf Mode and WakeCircuitry

FIG. 4 is a block diagram illustrating potential aspects of analytesensor system 408 according to embodiments of the present disclosure.Analyte sensor system 408 can correspond to analyte sensor system 308 ofFIG. 3B in some embodiments. The aspects of analyte sensor system 408shown in FIG. 4 can be implemented within subsystem 400 of analytesensor system 408 and can in general be used to manage a radio interfacebetween analyte sensor system 408 and any display devicescommunicatively coupled thereto via one or more wireless protocol(s),such as BLE, Wi-Fi, cellular and/or NFC. For example, applicationprogramming interface (API) 450 can be provided for display devices tocommunicate with processor 420 (e.g., processor 380) via radio 425,which can include a BLE or another RF or microwave transceiver (e.g.,transceiver 360). Processor 420 can be used to process analyte datagathered by sensor 405 (e.g., sensor 375).

As shown, within analyte sensor system 408, subsystem 400 can includesensor 405 (e.g., sensor 10), analog front end (AFE) 410 (e.g., sensorelectronics module 12), battery 415, processor 420, and radio 425. Thedesign of analyte sensor system 408, including with respect to subsystem400 as well as related software, enables multi-chip operation andmanagement, and particularly where such operation and/or management iscarried out in accordance with power savings principles described hereinand can involve implementing system configurations that support/maximizepower savings. For example, the design enables system startup,inter-chip communication, application task scheduling, maximization ofbattery life in storage as well as active modes, and utilization ofcontrol points and indications by API 450 associated with radio 425.

Analyte sensor system 408 can be in a storage mode before analyte sensorsystem 408 has been inserted into a host. In storage mode, radio 425 canbe at least partially disabled in order to save power. Likewise,processor 420 can be at least partially disabled, for example bydisabling a clock used by processor 420 (e.g., RTC 350). Furthermore, itis contemplated that, in the storage mode, radio 425 can be configuredto be in a deep sleep mode. This can advantageously extend/maximize thebattery life of analyte sensor system 408. In some embodiments, uponinteracting with display device 310, for example via NFC or visiblelight modulating and emitting protocols, analyte sensor system 408 canexit the storage mode. In some embodiments, upon detecting that sensor405 has been inserted into the host, analyte sensor system 408 canautomatically exit storage mode and enter an active mode.

For example, in some embodiments, during such a storage mode (e.g., ashelf mode) AFE 410 can comprise an ASIC configured to wake periodically(e.g., every 64 seconds), take an analyte current reading from sensor405 and, if that reading is greater than a predetermined threshold(e.g., configured during manufacturing), send a signal (e.g., wakesource 435) to processor 420, waking processor 420, which can thenperform a secondary sensor confirmation check. In some embodiments, sucha predetermined threshold can be determined from a mean break in currentof sensor 405 during hydration and electrochemical normalization thatoccurs after insertion of sensor 405 into the host (e.g., 20 nA). If thesecondary sensor confirmation check passes, analyte sensor system 408can be capable of determining that it has been deployed and begin aconnection process with one or more display devices. However, if theanalyte current reading from sensor 405 is not greater than thepredetermined threshold, AFE 410 can revert to the sleep mode until thenext wake period (e.g., 64 seconds after the preceding wake period) whenthe procedure can be repeated.

However, a time period between opening a box including analyte sensorsystem 408 and beginning such a connection process is not deterministic,as it can be affected by many factors including, but not limited to, atime taken to insert sensor 405 into the host, and a time taken forsensor 405 to properly hydrate once inserted into the host (which canvary from host to host). Variability in these and other relevant factorscan impair the user's experience as a result of unclear timelinesassociated with the process. In addition, because the trigger forexiting storage mode is a measured analyte current reading from sensor405 exceeding a predetermined threshold, static discharge to sensor 405and/or AFE 410 can undesirably trigger a false positive for exitingstorage mode, increasing the risk of battery 415 being partially orfully depleted by the time of actual deployment by a host. Accordingly,it may be desirable to provide a more defined sequence for initiallyexiting a storage or shelf mode that is less susceptible to timelinevariabilities and false wake-ups as described above.

Accordingly, in some embodiments, at the time of manufacture and/orfactory packaging, a shorting element 455 can be disposed in electricalcontact with each terminal of sensor 405 such that the terminals areelectrically short-circuited. In some embodiments, shorting element 455can comprise an electrically conductive wire or electrically conductivesheet. In some embodiments, shorting element 455 comprises molded orstamped low-resistance and/or electrically conductive foam configured toelectrically short both terminals of sensor 405 while sensor 405 isdisposed in its packaging, including the low-resistance and/orelectrically conductive foam. After disposing shorting element 455across the terminals of sensor 405, analyte sensor system 408 can beplaced in storage or shelf mode during which AFE 410 is configured towake periodically (e.g., every 64 seconds) and take an analyte currentreading from sensor 405.

However, contrary to the above-described embodiments, where an analytecurrent reading from sensor 405 exceeding the predetermined thresholdtriggers an exit of storage mode, here, a measured analyte currentreading from sensor 405 falling below a different predeterminedthreshold triggers an exit of storage mode. For example, while shortingelement 455 shorts the terminals of sensor 405, a measured analytecurrent reading from sensor 405 will be maximal or near maximal. Whenthe shorting element 455 is removed from the terminals of sensor 405, ameasured analyte current reading from sensor 405 will be zero, or nearzero, signaling that sensor 405 has been removed from its packaging andis likely in use. Upon exiting storage mode, analyte sensor system 408can be configured to immediately begin a Bluetooth or BLE pairingoperation, or another wireless communication protocol pairing operation,to establish a connection with at least one display device as will bedescribed in more detail in connection with one or more embodimentsbelow. In such embodiments, a secondary sensor check may not berequired. After a successful pairing analyte sensor system 408 canmonitor the analyte current reading from sensor 405 for signalcharacteristics indicative of sensor break-in and/or hydration toconfirm the analyte sensor system 408 is properly mounted to a body-wornreceptacle.

Embodiments utilizing such a shorting element 455 provide at least a fewadditional benefits. For example, a time interval required for pairingis reduced since the act of removing the shorting element 455 provides adeterministic time from which the process begins and analyte sensorsystem 408 need not wait for sensor hydration or break-in. In addition,static discharge no longer presents a risk for false wake up, since thetrigger is an analyte current reading from sensor 405 that is lower thana predetermined value, rather than an analyte current reading fromsensor 405 that is higher than the same or another predetermined value.In some embodiments, a light emitting diode (LED) disposed withinanalyte sensor system 408 (not shown) can be configured to blink orilluminate steadily when analyte sensor system 408 has entered theBluetooth pairing operation, providing further confirmation to a userthat the system is working as expected. Alternatively, a notificationmay be displayed on a display device, e.g., display device 310, toindicate that analyte sensor system 408 has entered the Bluetoothpairing operation.

In active mode, a low power mode (LPM) can still be used (e.g., toextend/maximize battery life), but RTC 350 can be activated/enabled.This can allow processor 420 to track time accurately and perform otherclock-based functions while still allowing for power savings. Forexample, RTC 350 can be used to perform error recovery using time-basedcounters and interrupts. The following error recovery scenarios areprovided by way of illustration. In one example, if no response messagesare received from radio 425 for a given amount of time, processor 420can reset radio 425. In another example, a periodic interrupt can beused where if logic of RTC 350 fails, analyte sensor system 408 can bereset by hardware logic. In additional implementations, if a message orsignal associated with wake source 435 (or AFE 410) is not received orfails, an interrupt (e.g., RTC interrupt) can be used to bring processor420 out of LPM and perform communication functions.

Processor 420 can act as a system controller for subsystem 400 withinanalyte sensor system 408. For example, after initializing, radio 425can enter a sleep state and wait for instruction from processor 420. AFE410 can initialize to a default state and likewise wait forconfiguration instructions/commands from processor 420. Processor 420can control resetting AFE 410 and/or radio 425 in case errors aredetected. Processor 420 can also self-reset if internal error conditionsare detected (e.g., using a hardware watchdog).

Subsystem 400 of analyte sensor system 8 can utilize a multi-chip (ormulti-module) design, in which case a hardware communication bus can beused for the exchange of data among the various chips (or modules).Examples of viable options for the hardware communication bus includeInter-Integrated Circuit (I2C or I2C) and Serial Peripheral Interface(SPI). SPI can be used to achieve a reduction in powers as well as anincrease in speed relative to I2C.

Wake source 435 and raw sensor data 430 can be used to maximize thebattery life of analyte sensor system 408. AFE 410 can typically be usedas a wake source for components of subsystem 400. Nevertheless, otherwake sources can be utilized. During normal operation, AFE 410 can allowprocessor 420 to enter an energy efficient lower power mode (LPM). Wakesource 435 can be used to signal processor 420 to exit LPM such that,e.g., processor 420 can execute operations not typically availableduring LPM. Wake source 435 can signal processor 420 in this mannerperiodically and trigger processor 420 to start processing or executingoperations. Analyte sensor system 408 can include multiple processors,and staged task processing can be implemented, in some cases inconnection with wake source 435, such that not all processors are activesimultaneously. This technique can reduce power consumption and henceextend battery life. By way of example, wake source 435 can cause firstsignal processor 420 to exit LPM and begin configuring the pertinenthardware and software of analyte sensor system 408 to initiate thetransfer of raw sensor (analyte) data from AFE 410.

Raw sensor data 430 can include hardware that transfers sensor datagathered by sensor 405 from AFE 410 to processor 420. Such data can bereferred to herein as raw sensor data or raw analyte data. Configuration440 can be a two-way interface between processor 420 and AFE 410. Insome cases, configuration 440 can be implemented using I2C, but SPI oranother interface configuration can also be used. Processor 420 andradio 425 can likewise use a SPI and/or I2C bus for communication anddata transfer. In some cases, additional hardware and software can beused to create an asynchronous interface between processor 420 and radio425 when using synchronous protocols (e.g., SPI and the like).

AFE 410 can sample raw analyte data from sensor 405 for a period of time(e.g., 7 minutes). During the sampling, processor 420 and a processor(e.g., baseband processor) within radio 425 can be held in low powermode (LPM). Once AFE 410 completes the sample, AFE 410 can send a signalto processor 420 indicating that processor 420 should exit LPM (i.e.,should wake up). AFE 410 can then transfer the raw analyte data toprocessor 420 via configuration 440. AFE 410 can then re-enter LPM.Processor 420 can then process the raw analyte data (e.g., to generatean estimated glucose value) and store the processed analyte data.Processor 420 can then signal the processor of radio 425 viacommunication interface 445 to communicate the processed analyte data toradio 425. Processor 420 can subsequently enter LPM while waiting forradio 425 to connect to a display device (e.g., display device 310).Once such a connection is made, processor 420 can exit LPM, and thedisplay device and processor 420 can exchange data, commands, and/ormessaging via radio 425.

API 450 can be used to interface with devices remote from analyte sensorsystem 408 over various wireless protocols. One example of such aprotocol is BLE. In this regard, API 450 can allow analyte sensor system408 to be configured by a user of a display device (e.g., display device310) running an application such as, for example, analyte sensorapplication 330. Analyte sensor application 330 can have been developedby the manufacturer of analyte sensor system 408 and/or display device310 or can be developed by any individual or entity. In the case thatthe BLE standard is used to couple a display device to analyte sensorsystem 408, BLE Characteristics can be configurable according to systemdesign parameters.

With the above description of aspects of systems and methods forwireless communication of analyte data, a number of specific and furtherimprovements will now be provided. It will be appreciated by one ofskill in the art upon studying the present disclosure that theseimprovements can be implemented using features and combinations offeatures of the example configurations described above, whether or notexplicit reference is made to the same.

Authentication and Pairing

In scenarios involving the connection of two devices over a network(wireless or otherwise), authentication and pairing can be used toprevent unauthorized devices from making a connection. For example,where sensitive data is being exchanged (e.g., personal analyteconcentration data), authentication can be used to prevent unauthorizeddevices or entities from gaining access to the data. In this regard,authentication and pairing protocols can be employed to establish orvalidate the identity of connecting devices. However, securely pairingan analyte sensor system, such as system 308, with a peripheral device,such as display device 310, can be challenging for users. Accordingly,several embodiments for automatically pairing such analyte sensorsystems to one or more display devices with minimal user input aredescribed below in connection with FIGS. 7-8B and 9-10B, respectively.

FIG. 7 illustrates a messaging diagram of a pairing operation betweenone or more analyte sensor system(s) 708 and one or more display devices710, according to some example embodiments. In some embodiments, ananalyte sensor system 708 and display device(s) 710 may correspond toanalyte sensor system 308 and any of display devices 310, respectively,as previously described in connection with FIGS. 3A-3E. FIG. 8A is aflowchart 800, illustrating various operations that can be performed inaccordance with embodiments of the disclosure. In some embodiments,flowchart 800 of FIG. 8A corresponds to operations and/or actionsperformed by analyte sensor system 708 of FIG. 7. FIG. 8B is a flowchart850 illustrating various operations that can be performed in accordancewith embodiments of the disclosure. In some embodiments, flowchart 850of FIG. 8B corresponds to operations and/or actions performed by displaydevice (s) 710 of FIG. 7.

The various tasks performed in connection with the proceduresillustrated in FIGS. 7-8B can be performed, for example, by respectiveprocessors executing instructions embodied in respective non-transitorycomputer-readable media. The tasks or operations performed in connectionwith the procedures can be performed by hardware, software, firmware, orany combination thereof incorporated into one or more of computingdevices. It will be appreciated upon studying the present disclosurethat such procedures can include any number of additional or alternativetasks or operations. The operations shown by way of example in FIGS.8A-8B need not be performed in the illustrated order, and the procedurescan be incorporated into more comprehensive procedures or processeshaving additional functionality not described in detail herein withspecific reference to FIGS. 8A-8B.

An example pairing operation will now be described in connection withFIG. 7. In some embodiments, before the operations described below, auser can download, for example from an app store, and/or otherwiseinitialize an application for monitoring an analyte concentration of theuser to display device 710. The user can complete a setup of theapplication, after which the application can instruct the user to deployanalyte sensor system 708 in preparation of a pairing operation betweenanalyte sensor system 708 and display device 710. The applicationrunning on display device 710 can then begin monitoring foradvertisement messages, e.g., BLE advertisement messages. Upondeployment, analyte sensor system 708 can be configured to wake up froma lower power or sleep mode, for example, as previously described inconnection with FIG. 4.

Upon waking, analyte sensor system 708 can be configured to generate arandom pairing key. Two concurrent advertisement messages (e.g.,advertisement message A 712 and advertisement message B 714) can begenerated and a radio of analyte sensor system 708 can transmit the twoconcurrent advertisement messages. In some embodiments, firstadvertisement message 712 can include one or more of the following: anindication of a manufacturer of analyte sensor system 708 (e.g.,Dexcom), an address identifying analyte sensor system 708 (e.g., a BLEaddress stored internally to a radio chip of analyte sensor system 708that identifies analyte sensor system 708 and/or the radio chip), anindication that a device or peripheral instance associated withadvertisement message 712 is connectable, and an indication ofout-of-band (OOB) authentication. In some embodiments, a peripheralinstance can be considered a software-based object corresponding to aparticular communication device, e.g., display device 710. In someembodiments, an indication of OOB authentication may indicate that oneor more additional messages will be transmitted to authenticate theconnection. In some embodiments, second advertisement message 714 caninclude one or more of the following: the indication of the manufacturerof analyte sensor system 708 (e.g., Dexcom), the address identifyinganalyte sensor system 708 (e.g., the BLE address stored internally tothe radio chip of analyte sensor system 708), an indication that adevice or peripheral instance associated with advertisement message 714is not connectable, and a payload comprising the random pairing key. Theaddress included in each of first and second advertisement messages 712,714 can be identical to one another. In some embodiments, the randompairing key can be encrypted before being inserted into and transmittedwithin advertisement message 714. In some embodiments, in addition or inalternative to being encrypted, the random pairing key can be furtherobscured by disposing nibbles and/or subsets of the random pairing keyin a proprietary pattern within the payload of advertisement message714. In such embodiments, display device 710 can be configured todecrypt and/or reconstruct the nibbles and/or subsets of the randompairing key based, for example, based on display device 710 havingand/or obtaining a priori programming and/or instructions configured toperform such decryption and/or reconstruction. In one example, such apriori programming and/or instructions can be downloaded from a server(add that it may use transmitter id to determine what to pull from theserver etc.)

Based on the monitoring, display device 710 can be configured to detecteach of first and second advertisement messages 712, 714. Display device710 can be configured to determine that first and second advertisementmessages 712, 714 are valid based at least in part on each message 712,714 indicating the same manufacturer (e.g., Dexcom) and/or based atleast in part on each message 712, 714 indicating the same address(e.g., identifying analyte sensor system 708). In some embodiments,where display device 710 detects more than one valid pair of messagesfitting the description of first and second advertisement messages 712,714, display device 710 can be configured to select the pair of validmessages having the highest received signal strength indicator (RSSI).For example, each of advertising messages 712, 714 would be expected tohave substantially similar RSSI values, since both messages aretransmitted from the same device in sufficiently close temporalproximity to one another.

Display device 710 can be further configured to extract and decrypt therandom pairing key from second advertisement message 714. Display device710 can be configured to generate and transmit a pairing request 716,addressed to analyte sensor system 708 as indicated by the address infirst advertisement message 712, and further comprising the decryptedrandom pairing key.

Analyte sensor system 708 can receive pairing request 716 and determinewhether the decrypted random pairing key within pairing request 716 isthe same as the random pairing key analyte sensor system 708 originallygenerated, encrypted and transmitted within second advertising message714. If the decrypted random pairing key is the same, analyte sensorsystem 708 can generate and transmit a pairing request acceptancemessage 718 to display device 710. Analyte sensor system 708 and displaydevice 710 can then enter a secure sensor communication session. In someembodiments, if the decrypted random pairing key is not the same as therandom pairing key analyte sensor system 708 originally generated,encrypted and transmitted within second advertising message 714, analytesensor system 708 can ignore pairing request 716.

Description now turns to flowchart 800 of FIG. 8A, describing operationsof, for example, analyte sensor system 708. Block 802 includes wakinganalyte sensor system 708. For example, analyte sensor system 708 canwake from a storage mode, a sleep mode, or a low-power mode upondeployment.

Block 804 includes generating and encrypting a pairing key. For example,upon waking, analyte sensor system 708 can be configured to generate arandom pairing key for pairing with another device, for example, displaydevice 710. Analyte sensor system 708 can be further configured toencrypt the random pairing key according to any suitable encryptionscheme.

Block 806 includes initializing a radio of a transceiver with a firstperipheral instance and a second peripheral instance. For example,analyte sensor system 708 can be configured to advertise itsavailability to pair utilizing two advertisement messages configured toallow automatic authentication and pairing between analyte sensor system708 and display device 710.

Block 808 includes setting a timeout counter. For example, the pairingprocess can have a set time interval after which, if pairing has yet tobe successful, the pairing process can be determined to have failed. Insome embodiments, analyte sensor system 708 can be configured to set an80-minute timeout counter. However, the present disclosure is not solimited, and any suitable time interval can be utilized.

Block 810 includes generating and transmitting a first advertisingmessage associated with the first peripheral instance and a secondadvertising message associated with the second peripheral instance. Forexample, analyte sensor system 708 can be configured to generate firstadvertisement message 712 comprising an indication of a manufacturer ofanalyte sensor system 708 (e.g., Dexcom), an address identifying analytesensor system 708 (e.g., a BLE address stored internally to a radio chipof analyte sensor system 708), an indication that a device or peripheralinstance associated with advertisement message 712 is connectable, andan indication of out-of-band (OOB) authentication. Analyte sensor system708 can also be configured to generate second advertisement message 714(FIG. 7) comprising the same indication of the manufacturer of analytesensor system 708 (e.g., Dexcom), the same address identifying analytesensor system 708 (e.g., the BLE address stored internally to the radiochip of analyte sensor system 708), an indication that a device orperipheral instance associated with advertisement message 714 is notconnectable, and a payload comprising the encrypted random pairing key.Analyte sensor system 708 can transmit first and second advertisementmessages 712, 714 concurrently, e.g., at the same time, in immediatesuccession, and/or in the same pairing session.

Block 812 includes determining whether a pairing request correspondingto the first peripheral instance has been received. For example, adevice attempting to pair with analyte sensor system 708, e.g., displaydevice 710 can transmit, and analyte sensor system 708 can receivepairing request 716 in response to the transmission of first and secondadvertisement messages 712, 714. If the determination at block 812 isnegative, block 814 includes determining whether the timeout counter hasexpired. If not, flowchart circles back to block 810. If so, flowchartadvances to block 820, where a manual pairing operation can occurbetween analyte sensor system 708 and display device 710, after whichflowchart 800 can enter a secure communication session for securelycommunicating analyte data at block 822.

If the determination at block 812 is affirmative, flowchart 800 advancesto block 816, which includes determining whether the pairing requestcomprises a valid pairing key. For example, analyte sensor system 708can be configured to determine whether a decrypted pairing key embeddedwithin pairing request 716 is the same pairing key that analyte sensorsystem 708 encrypted and transmitted in second advertisement message714. If the determination at block 816 is negative, flowchart 800circles back to block 814. If the determination at block 816 isaffirmative, flowchart 800 advances to block 818, which includesgenerating and transmitting a pairing request acceptance message. Forexample, analyte sensor system 708 can be configured to transmit pairingrequest acceptance message 718 back to display device 710. Flowchart 800then advances to block 822, entering a secure communication session forsecurely communicating analyte data.

Description now turns to flowchart 850 of FIG. 8B, describing operationsof, for example, display device(s) 710. At block 852 a display device,for example, display device 710 (FIG. 7) is ready to enter a pairingoperation. Block 854 includes initiating monitoring for pairabledevice(s). For example, display device 710 can be configured to monitorone or more communication channels for one or more messages indicativeof a device attempting to pair with display device 710.

Block 856 includes continuing monitoring for the pairable device(s). Forexample, display device 710 can be configured to continue monitoring theone or more communication channels for the one or more messagesindicative of a device attempting to pair with display device 710 for apredetermined time interval.

Block 858 includes determining whether a first advertisement messageassociated with a first peripheral instance has been received. Forexample, in some embodiments, display device 710 can be configured todetect and/or identify first advertisement message 712 based at least inpart on first advertisement message 712 including any one or more of acertain indication of a manufacturer of analyte sensor system 708 (e.g.,Dexcom, Inc., San Diego, Calif.), an address identifying analyte sensorsystem 708 (e.g., a BLE address stored internally to a radio chip ofanalyte sensor system 708), an indication that a device or peripheralinstance associated with advertisement message 712 is connectable, andan indication of out-of-band (OOB) authentication.

If the determination at block 858 is negative, flowchart 850 can circleback to block 856 and display device 710 continues monitoring. If thedetermination at block 858 is affirmative, flowchart 850 advances toblock 860, which includes determining whether a second advertisementmessage comprising the same address as the first advertisement has beenreceived. For example, display device 710 can be configured to detectand/or identify second advertisement message 714 based at least in parton second advertisement message 714 including an indication of the samemanufacturer as indicated in first advertisement message 712 (e.g.,Dexcom) and an indication of the same address as indicated in firstadvertisement message 712.

If the determination at block 860 is negative, flowchart 850 can circleback to block 856 and display device 710 continues monitoring. In someembodiments, more than one pair of first and second advertisementmessages 712, 714 can be received from more than one analyte sensorsystem. In such embodiments, if the determination at block 860 isaffirmative, flowchart 850 advances to block 862, where display device710 can be configured to select the first and second advertisingmessages having the highest received signal strength indication (RSSI).Selecting the qualifying advertising message pair with the highest RSSIcan facilitate authentication and pairing with the correct analytesensor system.

Block 864 includes extracting and decrypting a pairing key from thesecond advertising message. For example, analyte sensor system 708previously generated, encrypted and embedded a random pairing key intothe payload of second advertisement message 714. Display device 710 canbe configured to extract and decrypt this embedded pairing key.

Block 866 includes generating and transmitting a pairing request messagecomprising the decrypted pairing key. For example, display device 710can be configured to generate and transmit pairing request message 716having the decrypted pairing key received in second advertisementmessage 714 to analyte sensor system 708.

Block 868 includes determining whether the pairing request has beenaccepted. For example, display device 710 can determine that the pairingrequest initiated by the transmission of pairing request message 716 wasaccepted based on receiving pairing request acceptance message 718 fromanalyte sensor system 708, or alternatively, based on not receiving apairing request denial or negative acknowledgment message from analytesensor system 708 within a predetermined period of time aftertransmission of pairing request message 716.

If the determination at block 868 is negative, flowchart 850 advances toblock 872, which includes determining whether a timeout counter hasexpired. If yes, flowchart 850 advances to block 874, where a manualpairing of analyte sensor system 708 and display device 710, e.g.,manually entering a transmitter ID into display device 710, can takeplace and a secure communication session, e.g., for securelycommunicating encrypted analyte data, can be entered at block 870. Ifno, flowchart 850 circles back to block 856. If the determination atblock 868 is affirmative, a secure communication session can be enteredat block 870.

FIGS. 9-10B describe embodiments utilizing asymmetric cryptographic keys(e.g., using a single public key and multiple corresponding privatekeys) to automatically establish a secure link between an analyte sensorsystem and one or more peripheral display devices.

FIG. 9 illustrates a messaging diagram of a pairing operation between ananalyte sensor system 908 and one or more display devices 910, accordingto some example embodiments. In some embodiments, analyte sensor system908 and display device(s) 910 can correspond to analyte sensor system308 and any of display devices 310, respectively, as previouslydescribed in connection with FIGS. 3A-3E. FIG. 10A is a flowchart 1000illustrating various operations that can be performed in accordance withembodiments of the disclosure. In some embodiments, flowchart 1000 ofFIG. 10A corresponds to operations and/or actions performed by analytesensor system 908 of FIG. 9. FIG. 10B is a flowchart 1050 illustratingvarious operations that can be performed in accordance with embodimentsof the disclosure. In some embodiments, flowchart 1050 of FIG. 10Bcorresponds to operations and/or actions performed by display device(s)910 of FIG. 9.

The various tasks in connection with the procedures illustrated in FIGS.9-10B can be performed, for example, by respective processors executinginstructions embodied in respective non-transitory computer-readablemedia. The tasks or operations performed in connection with theprocedures can be performed by hardware, software, firmware, or anycombination thereof incorporated into one or more of computing devices.It will be appreciated upon studying the present disclosure that suchprocedures can include any number of additional or alternative tasks oroperations. The operations shown by way of example in FIGS. 10A-10B neednot be performed in the illustrated order, and the procedures can beincorporated into more comprehensive procedures or processes havingadditional functionality not described in detail herein with specificreference to FIGS. 10A-10B.

An example pairing operation will now be described in connection withFIG. 9. In some embodiments, before the operations described below, auser can download, for example from an app store, and/or otherwiseinitialize an application for monitoring an analyte concentration of theuser to display device 910. The application on display device 910 cancomprise a single public key 911 “Pub A” that corresponds, for example,to a particular product platform (e.g., analyte sensor system 908). Forexample, applications configured to run on display device 910 andreceive, monitor, and/or display analyte concentration data from a samemodel or class of models of analyte sensor 908 can be preloaded with, orhave public access to, public key 911 “Pub A,” which can be utilized toencrypt data. The application on display device 910 can also comprise aprivate key 913 “Priv B” configured to decrypt data previously encryptedwith a corresponding different single public key 917 “Pub B” preloadedon or publicly available to the particular product platform (e.g.,analyte sensor system 908).

Analyte sensor system 908 can comprise public key 917 “Pub B,” which isconfigured to encrypt data, and a unique private key 915 “Priv A,” whichis configured to decrypt data previously encrypted utilizing public key911 “Pub A” at display device 910. Public key 917 “Pub B” can bepre-loaded on each analyte sensor system 908 of a given product platformat the factory. In some embodiments, private keys 911, 913 can beobtained via secure download or by any other suitable method.

A public key is termed “public” because it is publicly available to orgenerally known by devices, while a private key is termed “private”because it is not publicly available to or known by all devices and iskept secret from all but authorized devices. As described herein eachPublic Key can encrypt data utilizing a common algorithm. A plurality ofunique Private Keys that are associated with the same single Public Keycan each comprise a unique algorithm configured to decrypt datapreviously encrypted with the associated Public Key's common algorithm.Thus, in such embodiments, encryption-to-decryption is one to many, as asingle common algorithm is utilized to encrypt data, while any one of aplurality of unique corresponding algorithms can be utilized to decryptthe previously encrypted data.

A user of display device 910 can complete a setup of the application,after which the user can deploy analyte sensor system 908 in preparationof a pairing operation to be conducted between analyte sensor system 908and display device 910. The application running on display device 910can begin monitoring for advertisement messages, e.g., BLE advertisementmessages. Upon activation, analyte sensor system 908 can be configuredto wake up from a lower power or sleep mode, for example, as previouslydescribed in connection with FIG. 4.

Upon waking, analyte sensor system 908 can transmit an advertisementmessage 912, utilizing a transceiver radio, thereby causing acommunication channel 914 to be established with display device 910. Oneor more additional communications between analyte sensor system 908 anddisplay device 910 (not shown) can occur during establishment ofcommunication channel 914. Private data, e.g., analyte values orindications of the same, is not yet sent, but communication channel 914can now be utilized to communicate encrypted data between analyte sensorsystem 908 and display device 910 for subsequently establishing a securecommunication channel.

Upon establishment of communication channel 914, display device 910 cangenerate a random number and encrypt it utilizing public key 911 “PubA.” Display device 910 can then transmit the encrypted random number 916to analyte sensor system 908 utilizing communication channel 914.

Upon receipt, analyte sensor system 908 can decrypt the encrypted randomnumber utilizing private key 915 “Priv A.” Analyte sensor system 908 canthen re-encrypt the random number utilizing public key 917 “Pub B.”Analyte sensor system 908 can then transmit the re-encrypted randomnumber to display device 910 utilizing communication channel 914.

Upon receipt, display device 910 can decrypt the re-encrypted randomnumber utilizing private key 913 “Priv B.” Display device 910 thencompares the decrypted random number with the originally generatedrandom number. If they are the same, communication between analytesensor system 908 and display 910 is authenticated and data 920 can nowbe transmitted securely. For example, if data 920 is transmitted bydisplay device 910, it can be encrypted by display device 910 utilizingpublic key 911 “Pub A” and decrypted by analyte sensor system 908utilizing private key 915 “Priv A.” Likewise, if data 920 is transmittedby analyte sensor system 908, it can be encrypted by analyte sensorsystem 908 utilizing public key 917 “Pub B” and decrypted by displaydevice 910 utilizing private key 913 “Priv B.” In some embodiments, data920 can comprise session data including one or more analyteconcentration values.

Description now turns to flowchart 1000 of FIG. 10A, describingoperations of, for example, analyte sensor system 908. Block 1002includes transmitting an advertisement message for establishing acommunication channel. For example, analyte sensor system 908 cantransmit advertising message 912 for establishing communication channel914.

Block 1004 includes receiving a random number encrypted utilizing afirst public key over the communication channel. For example, analytesensor system 908 can be configured to receive random number 916encrypted utilizing public key 911 “Pub A” from display device 910 overcommunication channel 914.

Block 1006 includes decrypting the encrypted random number utilizing afirst private key associated with the first public key. For example,analyte sensor system 908 can be configured to decrypt encrypted randomnumber 916 utilizing private key 915 “Priv A.”

Block 1008 includes re-encrypting the random number utilizing a secondpublic key. For example, analyte sensor system 908 can be configured tore-encrypt the now-decrypted random number from block 1006 utilizingpublic key 917 “Pub B.”

Block 1010 includes transmitting the re-encrypted random number over thecommunication channel. For example, analyte sensor system 908 can beconfigured to transmit re-encrypted random number 918 over unsecurecommunication channel 914 to display device 910.

Block 1012 includes transmitting sensor data encrypted utilizing thesecond public key over the communication channel. For example, uponauthentication of the communications between analyte sensor system 908and display device 910, sensor session data can be encrypted utilizingpublic key 917 “Pub B” and transmitted by analyte sensor system 908 todisplay device 910 over communication channel 914. In some embodiments,display device 910 can also be configured to transmit data securely overcommunication channel 914 by encrypting it with public key 911 “Pub A.”Analyte sensor system 908 can decrypt this encoded data utilizingprivate key 915 “Priv A.” Since all communications are now encrypted,communications over communication channel 914 are now secure.

Description now turns to flowchart 1050 of FIG. 10B, describingoperations of, for example, display device(s) 910. Block 1052 includesreceiving an advertisement message for establishing a communicationchannel. For example, display device 910 can be configured to receiveadvertising message 912 for establishing communication channel 914 fromanalyte sensor system 908.

Block 1054 includes generating a random number. For example, displaydevice 910 can be configured to generate a random number utilizing anysuitable generation method.

Block 1056 includes encrypting the random number utilizing a firstpublic key. For example, display device 910 can be configured to encryptthe random number utilizing public key 911 “Pub A.”

Block 1058 includes transmitting the encrypted random number utilizingthe communication channel. For example, display device 910 can beconfigured to transmit the encrypted random number 916 utilizingcommunication channel 914.

Block 1060 includes receiving the random number re-encrypted utilizing asecond public key. For example, display device 910 can be configured toreceive re-encrypted random number 918 (encrypted random number 916previously decrypted utilizing private key 915 “Priv A” thenre-encrypted utilizing public key 917 “Pub B” by analyte sensor system908).

Block 1062 includes decrypting the re-encrypted random number utilizinga second private key. For example, display device 910 can be configuredto decrypt re-encrypted random number 918 utilizing private key 913“Priv B.”

Block 1064 includes comparing the decrypted random number to the randomnumber originally generated. For example, display device 910 can beconfigured to compare the decrypted version of re-encrypted randomnumber 918 with the original random number generated by display device910 at block 1054.

Block 1066 includes authenticating a communication session based on adetermination that the decrypted random number and the random numberoriginally generated are the same. For example, display device 910 canbe configured to validate and/or authenticate that it is communicatingwith a trusted device (i.e., analyte sensor system 908) based on theabove comparison and a subsequent determination that the decryptedversion of re-encrypted random number 918 and the original random numbergenerated by display device 910 at block 1054 are the same number.

Block 1068 includes receiving sensor data encrypted utilizing the secondpublic key. For example, upon authentication of the communicationsbetween analyte sensor system 908 and display device 910, display device910 can be configured to receive sensor session data encrypted utilizingpublic key 917 “Pub B” and transmitted by analyte sensor system 908. Insome embodiments, display device 910 can also be configured to transmitdata securely by encrypting it with public key 911 “Pub A.” Analytesensor system 908 can decrypt this encoded data utilizing private key915 “Priv A.” Since all communications are now encrypted, communicationsover the communication channel 914 are now secure.

Selecting Low-Interference Channels for Communication

In some embodiments, initial advertising for establishing acommunication channel can occur during intervals where one or more otherdevices are concurrently communicating. Such interfering communicationscan adversely affect the efficiency and/or effectiveness of desiredcommunications on these channels. Accordingly, it can be desirable toselect a channel of a plurality of predetermined channels that has aleast amount of interference for such advertising and subsequentcommunication. Discussion regarding implementations that can provide forsuch channel selection will now follow in connection with FIGS. 11 and12 below.

FIG. 11 illustrates a portion of an analyte sensor system 1108,according to some example embodiments. In some embodiments, analytesensor system 1108 can correspond to analyte sensor system 308 aspreviously described in connection with any of FIGS. 3A-3E. Analytesensor system 1108 comprises an antenna 1102 coupled to or included in atransceiver 1160. Transceiver 1160 can include a frequency selectioncircuit 1162 configured to select a channel (e.g., frequency band) onwhich antenna 1102 can transmit and/or receive one or more signals.Antenna 1102 is further coupled to each of a plurality of filters F1,F2, F3 via respective switches Si, S2, S3. In some embodiments, filtersF1, F2, F3 can pass signals on BLE channels 37, 38 and 39 correspondingto 2402 MHz, 2426 MHz and 2480 MHz, respectively. However, the presentdisclosure is not so limited and filters F1, F2, F3 can be configured topass signals on any other frequencies and/or channels of any suitablewireless communication protocol. In addition, although three filters areillustrated, the present disclosure is not so limited, and any number offilters can be utilized.

In some embodiments, each filter F1, F2, F3 comprises a respectiveinductor L1, L2, L3, a respective capacitor C1, C2, C3 and a respectivediode D1, D2, D3 connected in series. However, the present disclosure isnot so limited and any filter, analog or digital, can be utilized. Eachfilter F1, F2, F3 can comprise a bandpass filter configured to passsignals within a respective frequency band (e.g. tuned to a respectivechannel for BLE advertising) to a power detection and channel selectioncircuit 1104 coupled to each filter F1, F2, F3. Channel power detectionand channel selection circuit 1104 can also be coupled to a switchcontroller 1106 and can be configured to send one or more signals toswitch controller 1106 that cause switch controller 1106 to select oneof the filters F1, F2, F3 by closing the respective switch S1, S2, S3and/or that cause switch controller 1106 to cause frequency selectioncircuit 1162 to select a channel (e.g., frequency band) on which antenna1102 can transmit and/or receive one or more signals.

In some embodiments, during intervals in which analyte sensor system1108 and/or a corresponding display device (not shown in FIG. 11) arenot scheduled to transmit any signals, switch controller 1106 can beconfigured to couple each of the filters F1, F2, F3 to antenna 1102,either simultaneously or sequentially, while channel power detection andchannel selection circuit 1104 is configured to measure an amount ofpower (for example, noise in this case) received on each channelcorresponding to each filter F1, F2, F3. Channel power detection andchannel selection circuit 1104 can be configured to compare the measuredpower on each corresponding channel and select the channel having thelowest measured power. The channel with the lowest measured power can beassumed to exhibit the lowest levels of interference to signalstransmitted and/or received by transceiver 1160 since all power measuredon a channel is inherently noise during intervals in which analytesensor system 1108 and/or a corresponding display device (not shown inFIG. 11) are not scheduled to transmit any signals. Channel powerdetection and channel selection circuit 1104 can be configured to selectthe channel corresponding to the lowest measured power and send at leastone signal to switch controller 1106 that causes switch controller 1106to cause frequency selection circuit 1162 to select the correspondingchannel for antenna 1102 to transmit and/or receive one or more signalsthereon. In different embodiments, the above-described interferencedetermination and channel selection can be carried out once, a pluralityof times, or periodically between each transmission interval to allowfor dynamic and/or periodic interferers to be accounted for. In someembodiments, another processor (e.g., a CPU) can override the channelselection provided by channel power detection and channel selectioncircuit 1104 for any number of reasons.

Description now turns to flowchart 1200 of FIG. 12, describingoperations of, for example, portions of analyte sensor system 1108 ofFIG. 11. Block 1202 includes successively coupling each of a pluralityof filtering circuits to an antenna, each of the filtering circuitsconfigured to pass a respective signal received by the antenna in arespective frequency channel. For example, switch controller 1106 can beconfigured to successively couple each of filters F1, F2, F3 to antenna1102 by closing a respective switch S1, S2, S3.

Block 1204 includes measuring a respective amount of power received oneach respective frequency channel while the analyte sensor system is notwirelessly communicating. For example, channel power detection andchannel selection circuit 1104 can be configured to measure a respectiveamount of power received on each respective frequency channel passed byfilters F1, F2, F3 while analyte sensor system 308 is not wirelesslycommunicating.

Block 1206 includes comparing the measured respective amounts of powerreceived on each respective frequency channel. For example, channelpower detection and channel selection circuit 1104 can be configured tocompare the measured respective amounts of power received on eachrespective frequency channel.

Block 1208 includes selecting the respective frequency channel havingthe lowest measured amount of power for the antenna to transmit one ormore signals. For example, channel power detection and channel selectioncircuit 1104 can be configured to select the channel corresponding tothe lowest measured power and send at least one signal to switchcontroller 1106 that causes switch controller 1106 to cause frequencyselection circuit 1162 to select the corresponding channel for antenna1102 to transmit and/or receive one or more signals thereon.

Reversing Slave-Master Roles of the Analyte Sensor System and DisplayDevices when Establishing Communication Sessions

In several of the above descriptions (e.g., FIGS. 7-10B), the analytesensor system acts as a slave device and the display device(s) act asthe master device at least in that the analyte sensor system transmitter(e.g., which acts as a BLE peripheral device) is configured to wakeperiodically (e.g., every 5 minutes) and advertise for a period of timein expectation of being monitored by the display device (e.g., whichacts as the BLE master, central device). Once the display device(s) hasdiscovered the analyte sensor system, a wireless connection isestablished and authenticated, command and control are accomplished viathe exchange of control endpoints and attributes. However, suchintermittent advertising by the analyte sensor system transmitter canrequire more power than passively monitoring one or more communicationchannels for advertisements.

Accordingly, the present disclosure also contemplates reversing theroles of the analyte sensor system and the display device(s) at leastwith respect to establishing communication sessions with one another. Atleast one embodiment is described below in connection with FIG. 13.However, the present disclosure is not so limited and this reversalconcept can be applied to any description herein regarding establishinga communication session between an analyte sensor system (or any of itscomponents) and a display device (or any of its components) such thatactions, steps or procedures described as being carried out by one canalternatively be carried out by the other and vice versa.

FIG. 13 illustrates a messaging diagram of a pairing operation betweenan analyte sensor system 1308 and one or more display devices 1310,according to some example embodiments. In some embodiments, analytesensor system 1308 and display device(s) 1310 can correspond to analytesensor system 308 and any of display devices 310, respectively, aspreviously described in connection with FIGS. 3A-3E.

Analyte sensor system 1308 can be configured to passively monitor foradvertisements from peripheral devices of an expected type (e.g.,display device 1310). Such monitoring can consume less power thanadvertising and has the advantage that it can be carried outcontinuously while one or more processors within analyte sensor system1308 are asleep, for example, as previously described in connection withFIG. 4. Upon display device 1310 waking, it can be configured to turn onits BLE radio and generate and transmit an advertisement message 1312.

Based on the monitoring, analyte sensor system 1308 can be configured todetect advertisement message 1312. In response to detection, and in somecases validation (e.g., as described elsewhere herein or according toany otherwise known validation and/or authentication procedure), ofadvertisement message 1312, analyte sensor system 1308 can be configuredto generate and transmit a pairing request 1316. Display device 1310 canreceive pairing request 1316 and, in response, generate and transmit apairing request acceptance message 1318 to analyte sensor system 1308.Analyte sensor system 1308 and display device 1310 can then enter asecure sensor communication session. In some embodiments, analyte sensorsystem 1308 can be configured to initiate a switch from functioning as aslave device to operating as the master device, as described above,based on satisfaction of one or more criteria, for example based ondetermination that a battery charge within analyte sensor system 1308has fallen below a predetermined level.

Display Device-Initiated Transmission of Session Data from the AnalyteSensor System

To conserve power in analyte sensor systems, some embodimentscontemplate intermittent connectivity between the analyte sensor systemand one or more display devices wherein the analyte sensor system wakesup periodically (e.g., every 5 minutes) from a low-power or sleep modeto perform an analyte concentration measurement and transmit anindication of the measurement to the display device. However, in suchembodiments, data (e.g., measurement data and/or analyte values) can besent from the analyte sensor system to the display device only duringthe periodic wake interval and some users may not want to wait anotherinterval before data is transmitted to the display device, especiallywhen the user has not received data in an extended period of time (e.g.,when the display device was out of range for an extended period of time.

Accordingly, some embodiments contemplate protocols where the analytesensor system is configured to monitor, from a low-power state, for asignal configured to wake the analyte sensor system, cause it toinitiate a pairing operation, and communicate session data withoutwaiting for a next periodic or otherwise scheduled wake interval.

FIG. 14 illustrates a messaging diagram of a pairing operation betweenan analyte sensor system 1408 and one or more display devices 1410,according to some example embodiments. In some embodiments, analytesensor system 1408 and display device(s) 1410 can correspond to analytesensor system 308 and any of display devices 310, respectively, aspreviously described in connection with FIGS. 3A-3E.

FIG. 14 illustrates analyte sensor system 1408 and one or more displaydevices 1410. Analyte sensor system 1408 can be in a low-power, or sleepmode, passively monitoring for a signal configured to wake the analytesensor system before a predetermined interval for waking has expired.

Display device 1410 can be configured to transmit a wake signal 1412(e.g., an RF, IR, optical, audio or any other suitable signal) having apredetermined pattern, magnitude or modulation to analyte sensor system1408. Upon detection of wake signal 1412, analyte sensor system 1408 canbe configured to wake from the low-power or sleep mode (e.g., aspreviously described in connection with FIG. 4) and transmit anadvertisement message 1414 for initiating a pairing operation. Inresponse to detection, and in some cases validation, of advertisementmessage 1412, display device 1410 can be configured to generate andtransmit a pairing request 1416. Analyte sensor system 1408 can receivepairing request 1416 and, in response, generate and transmit a pairingrequest acceptance message 1418 to display device 1410. Analyte sensorsystem 1408 and display device 1410 can then enter a secure sensorcommunication session in which analyte sensor system 1408 can transmitdata, e.g., sensor data, to display device 1410. In some embodiments,transmission of such sensor data can comprise fulfilling a backfillrequest for specific data from display device 1410 and/or any other dataat a time before a predetermined interval for waking analyte sensorsystem 1408 has expired.

Description now turns to flowchart 1500 of FIG. 15A, describingoperations of, for example, portions of analyte sensor system 1408 ofFIG. 14. Block 1502 includes preconfiguring an analyte sensor system toperiodically wake from a low-power passive monitoring mode according toa predetermined interval for waking the analyte sensor system. Forexample, analyte sensor system 1408 can be preconfigured to periodicallywake from a low-power passive monitoring mode according to apredetermined interval for waking analyte sensor system 308.

Block 1504 includes receiving a wake signal from a display device beforeexpiration of the predetermined interval while in the low-power passivemonitoring mode, thereby causing the analyte sensor system to wakebefore expiration of the predetermined interval. For example, analytesensor system 1408 can receive wake signal 1412 from display device 1410before expiration of the predetermined interval while in the low-powerpassive monitoring mode, thereby causing analyte sensor system 1408 towake before expiration of the predetermined interval.

Block 1506 includes transmitting an advertisement message in response tothe wake signal. For example, analyte sensor system 1408 can beconfigured to exit the low-power passive monitoring mode and transmitadvertisement message 1414 in response to receiving wake signal 1408.

Block 1508 includes receiving a pairing request from the display device.For example, analyte sensor system 1408 can be configured to receivepairing request 1416 from display device 1410.

Block 1510 includes transmitting a pairing request acceptance message tothe display device. For example, analyte sensor system 1408 can beconfigured to transmit pairing request acceptance message 1418 todisplay device 1410.

Block 1512 includes transmitting sensor data to the display device. Forexample, analyte sensor system 1408 can be configured to enter a securesensor communication session based on the above communications in whichanalyte sensor system 1408 can transmit data, e.g., sensor data, todisplay device 1410. In some embodiments, transmission of such sensordata can comprise fulfilling a backfill request for specific data fromdisplay device 1410 and/or any other data at a time before apredetermined interval for waking analyte sensor system 1408 hasexpired.

Description now turns to flowchart 1550 of FIG. 15B, describingoperations of, for example, portions of display device 1510 of FIG. 14.Block 1552 includes transmitting a wake signal to an analyte sensorsystem that is in a low-power passive monitoring mode. For example,display device 1410 can be configured transmit wake signal 1412 toanalyte sensor system 1408 while in a low-power passive monitoring mode.

Block 1554 includes receiving advertisement message responsive to thewake signal. For example, display device 1410 can be configured toreceive advertisement message 1414, responsive to wake signal 1408, fromanalyte sensor system 1408.

Block 1556 includes transmitting a pairing request to the analyte sensorsystem. For example, display device 1410 can be configured to transmitpairing request 1416 to analyte sensor system 1408.

Block 1558 includes receiving a pairing request acceptance messageresponsive to the pairing request. For example, display device 1410 canbe configured to receive pairing request acceptance message 1418,responsive to pairing request 1416, from analyte sensor system 1408.

Block 1560 includes receiving sensor data from the analyte sensorsystem. For example, display device 1410 can be configured to enter asecure sensor communication session based on the above communications inwhich display device 1410 receives data, e.g., sensor data, from analytesensor system 1408. In some embodiments, transmission and reception ofsuch sensor data can comprise fulfilling a backfill request for specificdata from display device 1410 and/or any other data at a time before apredetermined interval for waking analyte sensor system 1408 hasexpired.

Utilizing Stickers Comprising NFC Tags for Pairing Analyte Sensor Systemand Display Device

In some embodiments, initial pairing between an analyte sensor systemand a display device requires verifying and validating that the analytesensor system and the display device are authorized to connect to andcommunicate with one another. Some embodiments require a user tomanually enter a serial number or the like from the analyte sensorsystem and/or its packaging into an application running on the displaydevice as a step in performing such initial verification and validation.However, such procedures can be cumbersome for users. Accordingly, thepresent disclosure contemplates initially pairing an analyte sensorsystem to one or more display devices without requiring manual entry ofsuch serial numbers or the like by a user, thereby providing a simpler,streamlined setup experience for the user.

FIG. 16 illustrates an NFC tag 1602 embedded in a sticker 1604, whichcan be utilized to initially transfer identifying information for ananalyte sensor system 308, for example, as previously described inconnection with at least FIGS. 3A-3E, to a display device 310. Duringmanufacture, NFC tag 1602 can be embedded in sticker 1604 andpre-programmed with a pairing key (e.g., a BLE encryption key). At thetime of kitting of analyte sensor system 308, sticker 1604 can be fixedto analyte sensor kit box 398 (see FIG. 3D). When the user is ready topair analyte sensor system 308 with a particular NFC-enabled displaydevice 310, the user can physically move display device 310 sufficientlyclose to sticker 1604 (and NFC tag 1602 therein) (e.g., within severalcentimeters) such that display device 310 is able to retrieve thepairing key from NFC tag 1602 within sticker 1604 via NFC. In someembodiments, physically moving display device 310 sufficiently close tosticker 1604 can comprise tapping display device 310 against sticker.Then, utilizing the pairing key, display device 310 can be furtherconfigured to initiate a pairing protocol with analyte sensor system308, or alternatively participate in completion of a pairing protocolinitiated by analyte sensor system 308, according to any embodimentdescribed in this disclosure, or according to any other pairingprotocol. For example, in some embodiments, analyte sensor system 308may be configured to pair, or initiate pairing, with display device 310utilizing the pairing key. That is, display 310 need not initiate apairing process. For example, analyte sensor system 308 may beconfigured to advertise, while display 310 utilizes the pairing key insubsequent communications with analyte sensor system 308 to complete thepairing process.

Description now turns to flowchart 1700 of FIG. 17, describingoperations of, for example, any display device described herein. Block1702 includes physically moving a short-range wireless communicationprotocol-enabled display device sufficiently close to a stickerphysically disposed on one of an analyte sensor system or a packagingfor the analyte sensor system, comprising a short-range wirelesscommunications tag having pre-programmed thereon a pairing key, suchthat the display device is able to retrieve the pairing key from the tagvia the short-range wireless communication protocol. In someembodiments, the tag may further include one or more of sensor-relatedinformation, a sensor expiration date, license information, calibrationinformation, or any other information. In some embodiments, theshort-range wireless communications protocol may be an NFC protocol andthe tag may be an NFC tag. For example, at the time of initial pairingof analyte sensor system 308 and NFC-enabled display device 310, a usercan physically move display device 310 sufficiently close to sticker1604, comprising NFC tag 1602 having pre-programmed thereon a pairingkey, such that display device 310 is able to retrieve the pairing keyfrom NFC tag 1602 via NFC.

Block 1704 includes pairing the display device with the analyte sensorsystem for a wireless protocol different from the short-range wirelesscommunication protocol utilizing the retrieved pairing key. For example,display device 310 can pair with analyte sensor system 308 for awireless protocol different from the short-range wireless communicationprotocol (e.g., Wi-Fi, Bluetooth, BLE, cellular or any other suitablecommunication protocol) utilizing the pairing key retrieved from NFC tag1602 according to any embodiment described in this disclosure, oraccording to any other pairing protocol.

Utilizing Optical Means for Initiating Establishment of a SecureConnection with an Analyte Sensor System

Some embodiments, where secure communication between an analyte sensorsystem and one or more display devices are established, require a userto read a transmitter ID affixed to the analyte sensor system andmanually enter the transmitter ID into the one or more display devicesto establish the secure connection. Such embodiments can further requirea user to remember this transmitter ID to establish future secureconnections with one or more other display devices. Establishing securecommunications in this manner can be time consuming (e.g., taking 5 to30 minutes to establish) and can provide a sub-optimal user experience.

Accordingly, some embodiments are disclosed herein where a displaydevice is configured to utilize a light emitting source to transmit thetransmitter ID, or another secret key associated with the analyte sensorsystem, to initiate a secure pairing process between the display deviceand the analyte sensor system. As will become apparent from thedescription below, such embodiments provide a solution that does notrequire the user to read the transmitter ID and manually enter it intothe display device, allowing secure communications to be establishedfaster and with less user intervention, thereby providing a morestreamlined user experience.

FIG. 18 illustrates a block diagram of several features of a system forwirelessly communicating analyte sensor data, according to some exampleembodiments. FIG. 18 includes a display device 1810 and an analytesensor system 1808. Display device 1810 can correspond to any displaydevice described herein, for example display device 310 of FIG. 3B.Accordingly, display device 1810 can include any or all of the elementspreviously described in connection with any such corresponding displaydevice. Analyte sensor system 1808 can correspond to any display devicedescribed herein, for example analyte sensor system 308 of FIG. 3B.Accordingly, analyte sensor system 1808 can include any or all elementspreviously described in connection with any such corresponding analytesensor system.

Display device 1810 is illustrated as further comprising pairingsoftware 1830 configured to carry out communication protocols at leastas described herein for establishing a secure communication with atleast analyte sensor system 1808. Pairing software 1830 can correspondto a portion of analyte sensor app 330 of FIG. 3B or can be softwareconfigured separately therefrom.

Display device 1810 further comprises a display and/or light source 1845(e.g., a light emitting diode, a flash, an infra-red blaster, or anyother suitable light emitting source) configured to display a pattern ofmodulated light configured to transmit information to analyte sensorsystem 1808 at least related to the process of establishing the securecommunication with display device 1810 as will be described below. Insome cases, the modulated light is light in the spectrum visible to thehuman eye. However, the present disclosure is not so limited and themodulated light can be light in any portion of the electromagneticspectrum such as infra-red light.

Display device 1810 can be further configured to communicate with atleast analyte sensor system 1808 on a communication channel separatefrom the modulate light communications, for example, BLE, Wi-Fi, NFC,cellular, or any other suitable communication protocol, as will bedescribed in more detail below. Such a separate communication channelcan provide secure communications between display device 1810 andanalyte sensor system 1808 upon its establishment.

Analyte sensor system 1808 is illustrated as further comprising lightsensor 1805 configured to sense and/or receive modulated light encodingat least one of a wakeup signal and a first security code associatedwith display device 1810 from display/light source 1845 of displaydevice 1810.

Analyte sensor system 1808 further comprises a processor/ASIC 1890configured to receive an indication of the wakeup signal and the firstsecurity code from light sensor 1895. Processor/ASIC 1890 can beconfigured to detect and/or otherwise recognize the wakeup signal andtransmit an interrupt or wake signal to a second processor 1880responsive to the detection and/or recognition. The interrupt and/orwakeup signal can be configured to wake up at least a portion of thesecond processor 1880. Processor/ASIC 1890 can be further configured topass the received first security code to second processor 1880 forverification, further processing, or use in further processing of otherdata. In some embodiments, processor/ASIC 1890 can correspond to one ormore processors and/or wakeup detection circuits as previously describedin connection with FIG. 4, for example, AFE 410, processor 420 or atleast a portion of radio 425. In some embodiments, second processor 1880can correspond to processor 380 as previously described in connectionwith FIG. 3B.

Responsive to receipt of the first security code, second processor 1880can be configured to encrypt a second security code utilizing the firstsecurity code and cause the encrypted second security code to bebroadcasted to display device 1810 via a method or communicationprotocol other than the modulate light communications, for example, BLE,Wi-Fi, NFC, cellular, or any other suitable communication protocol. Thesecond security code can be a unique security code corresponding toand/or associated with analyte sensor system 1808.

Responsive to receipt of the encrypted second security code, displaydevice 1810 can be configured to validate the encrypted second securitycode utilizing any suitable validation method or protocol. Based on thevalidation, display device 1810 can be configured to start securecommunication with analyte sensor system 1808 via a communicationprotocol other than the modulate light communications, for example, BLE,Wi-Fi, NFC, cellular, or any other suitable communication protocol. Uponestablishment of the secure communication with analyte sensor system1808, analyte sensor system 1808 can be configured to transmit at leastanalyte concentration data encrypted utilizing the second security codeor utilizing another security code display device 1810 is configured todecrypt. Accordingly, embodiments according to FIG. 18 canadvantageously allow secure pairing and subsequent communication betweendisplay device 1810 and analyte sensor system without a user having tomanually read and/or enter a transmitter ID into either display device1810 or analyte sensor system 1808.

Description now turns to flowchart 1900 of FIG. 19A, describingoperations of, for example, any display device described herein withrespect to embodiments previously described in connection with FIG. 18.Block 1902 includes transmitting at least one of a wakeup signal and afirst security code, as modulated visible light, to an analyte sensorsystem. For example, display device 1810 can be configured to transmitthe wakeup signal and the first security code, corresponding to and/orassociated with display device 1810, via display/light source 1845, toanalyte sensor system 1808.

Block 1904 includes receiving a second security code encrypted utilizingthe first security code from the analyte sensor system. For example,display device 1810 can be configured to receive the second securitycode, encrypted utilizing the first security code. In some embodiments,display device 1810 can receive the encrypted second security coderesponsive to transmitting the wakeup signal and the first security codeto analyte sensor system 1808 and/or responsive to analyte sensor system1808 receiving the wakeup signal and the first security code. In someembodiments, the encrypted second security code can be received via acommunication channel and/or utilizing a different communicationprotocol than the modulated visible light, for example, BLE, Wi-Fi, NFC,cellular, or any other suitable communication protocol.

Block 1906 includes verifying the encrypted second security code. Forexample, display device 1810 can be configured to verify that the secondsecurity code corresponds to a predetermined, previously known orotherwise determinable security code and/or that the second securitycode was encrypted utilizing the first security code corresponding toand/or associated with display device 1810.

Block 1908 includes establishing a secure communication channel with theanalyte sensor system responsive to the verifying. For example, uponverifying the encrypted second security code, display device 1810 can beconfigured to establish a secure communication channel utilizing adifferent communication protocol than the modulated visible light, forexample, BLE, Wi-Fi, NFC, cellular, or any other suitable communicationprotocol.

Block 1910 includes receiving analyte concentration data from theanalyte sensor system over the secure communication channel. Forexample, in some embodiments, display device 1810 can be configured toreceive analyte concentration data, encoded utilizing the secondsecurity code corresponding to and/or associated with analyte sensorsystem 1808, from analyte sensor system 1808 over the BLE communicationchannel.

Description now turns to flowchart 1950 of FIG. 19B, describingoperations of, for example, any analyte sensor system described hereinwith respect to embodiments previously described in connection with FIG.18. Block 1952 includes receiving at least one of a wakeup signal and afirst security code, as modulated visible light, from a display device.For example, analyte sensor system 1808 can be configured to receive thewakeup signal and the first security code, corresponding to and/orassociated with display device 1810, via light sensor 1895, from displaydevice 1810.

Block 1954 includes transmitting a second security code encryptedutilizing the first security code from the analyte sensor system. Forexample, analyte sensor system 1808 can be configured to transmit thesecond security code, encrypted utilizing the first security code. Insome embodiments, analyte sensor system can transmit the encryptedsecond security code responsive to receiving the wakeup signal and thefirst security code. In some embodiments, the encrypted second securitycode can be transmitted via a communication channel and/or utilizing adifferent communication protocol than the modulated visible light, forexample, BLE, Wi-Fi, NFC, cellular, or any other suitable communicationprotocol.

Block 1956 includes establishing a secure communication channel with thedisplay device. For example, analyte sensor system 1808 can beconfigured to establish or participate in the establishment of a securecommunication channel with display device 1810 utilizing a differentcommunication protocol than the modulated visible light, for example,BLE, Wi-Fi, NFC, cellular, or any other suitable communication protocol.

Block 1958 includes transmitting analyte concentration data over thesecure communication channel. For example, in some embodiments, analytesensor system 1808 can be configured to transmit analyte concentrationdata, encoded utilizing the second security code corresponding to and/orassociated with analyte sensor system 1808, to display device 1810 overthe BLE communication channel.

User Alert for Inability to Connect an Analyte Sensor System to aDetected Display Device

Several embodiments are disclosed herein where an analyte sensor systemis configured to transmit sensor data to a paired display device (e.g.,a smart phone or a smart watch) such that a user can easily view thesensor data on the display device. In some embodiments, transmittingthis sensor data to the display device is performed periodically and/orintermittently to reduce average power consumption of the analyte sensorsystem. Accordingly, the display device can periodically connect withand disconnect from the analyte sensor system. However, there can beinstances where the user is wearing the analyte sensor system while thedisplay device is nearby, but the display device is unable to connectwith the analyte sensor system, preventing sensor data and/or other datafrom being transmitted from the analyte sensor system to the displaydevice or vice versa. One common cause of such inability to connect islow signal strength (SSI) between the display device and the analytesensor system. Such low signal strength can have a variety of causes,including but not limited to radio frequency (RF) obstructions, a userlaying on the analyte sensor system or other RF interference.Accordingly, the present disclosure contemplates alerting a user of adisplay device when the display device detects an advertisement messagefrom an analyte sensor system but is unable to connect with the analytesensor system, thereby allowing the user to perform one or more actionslikely to increase the probability of establishing a connection during anext attempt.

FIG. 20 illustrates a flowchart 2000 describing operations of, forexample, any display device described herein with respect to alerting auser when the display device detects an advertisement message from anyanalyte sensor system described herein but is unable to connect with theanalyte sensor system.

Block 2002 includes detecting an advertisement message from an analytesensor system. For example, any display device described herein candetect an advertisement message from any analyte sensor system describedherein.

Block 2004 includes attempting to establish a connection with theanalyte sensor system responsive to the advertisement message. Forexample, the display device can be configured to attempt to establish aconnection with the analyte sensor system according to any pairingand/or connection protocol disclosed herein or according to any othersuitable pairing and/or connection protocol.

Block 2006 includes determining that the attempt to establish theconnection with the analyte sensor system has failed. For example, aftera predetermined period of time attempting but failing to establish theconnection with the analyte sensor system, the display device can beconfigured to make a determination that the attempt to establish theconnection with the analyte sensor system has failed.

Block 2008 includes generating an alert on the display device indicatingthat the analyte sensor system has been detected but an attempt toestablish the connection with the analyte sensor system has failed. Forexample, the display device can be configured to generate anyappropriate alert, for example and not limitation, “Hi [User], Your[smartphone/smartwatch] is able to see your [analyte sensorsystem/transmitter] somewhere in your vicinity, however, was not able toconnect to it to receive data. Please try changing your orientation withrespect to your [smartphone/smartwatch] and other possible RFobstructions within [5 minutes] so that the next connection attempt hasa better chance of success.” In some embodiments, the alert can furthercomprise at least one suggested user intervention for improving theprobability of establishing the connection with the analyte sensorsystem on a subsequent connection attempt.

Direct Pairing of a Smartwatch or Other Display Directly to an AnalyteSensor System

In some cases, a user of an analyte sensor system may want to pair theanalyte sensor system with more than one display device, for example, asmartphone and a smartwatch. For example, it can be more convenient toview analyte concentration data on a smaller display device worn by theuser, such as a smartwatch. However, while potentially easier to viewanalyte concentration data and/or alerts at a glance, it can be morecumbersome to input information or to initiate pairing processes in suchsmaller display devices due at least in part to more limited user inputfunctions, e.g., the inability or difficulty of providing a fullkeyboard or numeric pad on their smaller displays. Accordingly, severalembodiments are contemplated that allow direct, secure pairing of adisplay device, such as a smartwatch, with an analyte sensor systemwithout requiring a user to manually enter a transmitter ID, serialnumber or code associated with the analyte sensor system into thesmartwatch for either initial pairing or subsequent connection and/orreconnection with the analyte sensor system. Description of suchembodiments follows with reference to at least FIGS. 3A-3C. For thepurpose of illustration only, a smartphone and a smartwatch (examples ofdisplay devices 310 as previously described in connection with FIGS.3A-3C) can both connect with analyte sensor system 308. For ease ofrepresentation, a first display device, e.g., a smartphone, cancorrespond to display device 310 a, while a second display device, e.g.,a smartwatch, can correspond to display device 310 b.

Analyte sensor system 308 can already be paired and/or otherwiseconnected with display device 310 a (e.g., a smartphone). To initiateconnection of display device 310 b (e.g., a smartwatch) to analytesensor system 308, a user can select an option to add a display deviceon the analyte monitoring application on display device 310 a (e.g.,analyte sensor app 330 of FIG. 3B). Selecting the option to add displaydevice 310 b on an app running on display device 310 a can be an easieruser interaction, since a display on display device 310 a can be largerthan a display on display device 310 b. However, the present disclosureis not so limited, and a user could alternatively select an option toadd a display device on a similar analyte sensor app 330 running ondisplay device 310 b. In some embodiments, analyte sensor app 330 caninclude a filtering option that determines or limits what types ofsmartwatches or other display devices the user can pair with analytesensor system 308 based on display device functionality, versions,and/or compatibility (e.g., 3E, 4G, LTE, 5G, Wi-Fi, NFC, Bluetooth, BLEsupport, etc.). The filtering option, for example, may also provide anindication whether the analyte sensor system 308 can support adirect-to-watch communication with a display device (e.g., asmartwatch). For example, upon selecting the option to add display onthe analyte sensor app 330 (e.g., on the display 310 a), a signal or afeedback message may be presented on the app notifying the user that theanalyte sensor system 308 is not compatible with display device 310 b,and/or cannot support a direct-to-watch communication. For example, thismay be because the version or model of the analyte sensor system 308does not support a direct-to-watch feature or the firmware running onthe analyte sensor system 308 may be out of date. Alternatively, in someexamples, if the analyte sensor system 308 can support a direct-to-watchcommunication with display device 310 b (e.g., a smartwatch), a feedbackmessage on the app, upon selection of the option to add a display (e.g.,display device 310 b), may indicate that the analyte sensor system 308can support a direct-to-watch communication. In one example, this may bebecause the analyte sensor system 308 is of the correct version/modeland/or has the correct/up-to-date firmware version.

Further in some examples, instead of a signal or a feedback message, theoption of selecting a display in the analyte sensor app 330 may begreyed out, if the analyte sensor system 308 (that is already incommunication with display 310 a) cannot support a direct-to-watchcommunication, thus not allowing the user to select such an option. Yetin another example, the option may not be greyed out, if the analytesensor system 308 (that is already in communication with display 310 a),for example, can support a direct-to-watch communication with a newdisplay device 310 b (e.g., a smartwatch).

Responsive to the user selection to add a display device, display device310 a or display device 310 b can transmit a signal or message toanalyte sensory system 308 indicating that a new device has requestedpairing.

Responsive to the signal or message indicating a new device hasrequested pairing, analyte sensor system 308 can enter a pairing mode inwhich analyte sensor system 308 is configured to transmit advertisementmessages periodically or continuously for a predetermined interval oftime. In some embodiments, the predetermined period of time during whichanalyte sensor system 308 periodically advertises for connection withdisplay device 310 b (e.g., a smartwatch) is significantly longer thanit would otherwise be for another type of display device (e.g., for asmartphone, etc.), for example, 10 minutes versus 20 seconds. However,the present disclosure is not so limited and predetermined period oftime can be substantially the same as for any other type of displaydevice. In another example, the analyte sensor system 308 may not entera pairing mode responsive to the signal or message indicating a newdevice has requested pairing. Instead, analyte sensor system 308 maysolicit connection from the new display device until its whitelist isfull. In such an example, the predetermined period time may vary (e.g.,it can be longer, shorter or the same).

Responsive to detecting, identifying and/or receiving the advertisementmessage, display device 310 b can display a “pair” notification that theuser selects to initiate the pairing process. Accordingly, displaydevice 310 b can be configured to receive an input from the user thatinitiates the pairing process in response to displaying the “pairnotification.”

Optionally, responsive to receiving the input from the user thatinitiates the pairing process, display device 310 b can transmit asignal to display device 310 a indicating the input has been receivedfrom the user.

Display device 310 a can transmit pairing and/or authenticationinformation (e.g., a transmitter ID or serial number corresponding toanalyte sensor system 308, and/or one or more pairing and/or encryptionkeys) to display device 310 b. In this way, a user is not required toenter the transmitter ID or any other similar identifying informationcorresponding to analyte sensor system 308 into display device 310 b toallow pairing. In one example, this may be performed responsive toreceiving the signal from display device 310 b indicating the input hasbeen received from the user.

In some other embodiments, display device 310 b can be configured toreceive some or all of the pairing and/or authentication informationfrom a separate server, for example server system 334 of FIG. 3A. Insuch embodiments, one might contemplate that the sever and displaydevice 310 b have established a communication channel that has beenpreviously authenticated, which may be based on authenticationinformation provided by display device 310 a. In such embodiments,responsive to receiving the input from the user that initiates thepairing process, display device 310 b can transmit the signal indicatingthe input has been received from the user to server system 334 ratherthan or in addition to display device 310 a.

Responsive to receiving the pairing and/or authentication informationfrom display device 310 a and/or server system 334, display device 310 bcan be configured to pair with analyte sensor system 308 according toany pairing protocol described herein or otherwise known. In someembodiments, this pairing process can be carried out in the backgroundsuch that the user is not aware or notified of steps in the procedurenot requiring explicit input from the user. Accordingly, a user caneasily pair a smaller display device, such as a smartwatch, to analytesensor system 308 without being required to enter identifyinginformation for analyte sensor system 308 into the smartwatch, providinga more streamlined experience to the user. Once a successful pairing hasbeen performed, it will be appreciated that the display device 310 bwill receive analyte related data from the analyte sensor system 308 andprovide such data and/or information related to the analyte data to theuser (e.g., estimated glucose values, notifications, alarms, alerts,etc., as described herein).

Description now turns to flowchart 2100 of FIG. 21A, describingoperations of, for example, a first display device 310 a (e.g., asmartphone) as previously described above. Block 2102 includes receivingfrom a user, on a first display device, an input indicative of a requestto pair a second display device to an analyte sensor system. Forexample, as previously described, a user can select an option to add adisplay device on the analyte monitoring application on display device310 a (e.g., analyte sensor app 330 of FIG. 3B). First display device310 a can already be paired and in communication with analyte sensorsystem 308.

Block 2104 includes transmitting a first signal to the analyte sensorysystem indicating that the second display device has requested pairing.For example, as previously described, display device 310 a can transmita first signal to analyte sensor system 308 indicating that displaydevice 310 b has requested pairing. As previously described,transmitting this signal to analyte sensor system 308 can cause analytesensor system 308 to enter optionally a pairing mode in which analytesensor system 308 periodically transmits advertisement messages for apredetermined interval of time.

Block 2106 includes receiving a second signal from the second displaydevice indicating the user has initiated a pairing process between thesecond display device and the analyte sensor system. For example, aspreviously described, a user may acknowledge a “pair” notificationdisplayed by display device 310 b by providing user input to displaydevice 310 b, and display device 310 b may or may not transmit a secondsignal indicating the user has initiated the pairing process to displaydevice 310 a.

Block 2108 includes, responsive to receiving the second signal from thesecond display device, transmitting a transmitter ID corresponding tothe analyte sensor system to the second display device. For example, aspreviously described, responsive to receiving the second signal fromdisplay device 310 b, display device 310 a can transmit pairing and/orauthentication information (e.g., a transmitter ID or serial numbercorresponding to analyte sensor system 308, and/or one or more pairingand/or encryption keys) to display device 310 b. Display device 310 bcan use this pairing and/or authentication information to pair withanalyte sensor system 308.

Description now turns to flowchart 2150 of FIG. 21B, describingoperations of, for example, a second display device 310 a (e.g., asmartwatch) as previously described above. Block 2152 includes receivingone or more advertisement messages from an analyte sensor systemtransmitted responsive to a user selection on a first display device topair a second display device with the analyte sensor system. Forexample, as previously described, a user can select an option to add adisplay device on analyte monitoring application 330 on display device310 a (FIG. 3B), and analyte sensor system 308 can be configured tooptionally enter a pairing mode, transmitting advertisement messagesperiodically for a predetermined interval of time. In such embodiments,first display device 310 a can already be paired with and incommunication with analyte sensor system 308.

Block 2154 includes displaying a notification of a pairing processresponsive to receiving the one or more advertisement messages. Forexample, as previously described, responsive to detecting, identifyingand/or receiving the advertisement messages, display device 310 b candisplay a “pair” notification to the user.

Block 2156 includes, responsive to receiving an input for initiating thepairing process from the user, optionally transmitting a signalindicating the input has been received from the user to the firstdisplay device. For example, as previously described, responsive toreceiving the input from the user that initiates the pairing process,display device 310 b may or may not transmit a signal to display device310 a indicating the input has been received from the user.

Block 2158 includes, receiving a transmitter ID corresponding to theanalyte sensor system from the first display device. For example, aspreviously described, display device 310 a can transmit and displaydevice 310 b can receive pairing and/or authentication information(e.g., a transmitter ID or serial number corresponding to analyte sensorsystem 308, and/or one or more pairing and/or encryption keys).

Block 2160 includes establishing a secure connection with the analytesensor system utilizing the transmitter ID corresponding to the analytesensor system. For example, as previously described, responsive toreceiving the pairing and/or authentication information, display device310 b can be configured to pair with analyte sensor system 308 accordingto any pairing protocol described herein or known generally.

Data Capture

Description below references components at least as disclosed in FIGS.3A-3E, however, the description is not so limited, and can correspond orapply to any other components described throughout this disclosure.

In some circumstances a user may want to couple more than one displaydevice to their analyte sensor system (e.g., analyte sensor system 308),for example a smartphone and a wearable smartwatch, or their ownpersonal smartphone or smartwatch and a medical device, for example,utilized by a health care provider in connection with managing a medicalcondition. Because it is desirable to preserve battery life of analytesensor system 308, analyte sensor system 308 can be configured toinitially pair and connect with a display device, transfer data to thedisplay device, disconnect from the display device to enter a low-powerand/or sleep mode to preserve battery, and then periodically reconnectto the display device based on a predetermined connection interval(e.g., every 5 minutes). While several embodiments described in thisdisclosure utilize a “predetermined” connection interval, the presentdisclosure also contemplates the use of similar connection intervalswhose duration and/or frequency of occurrence are not predetermined.Accordingly, embodiments describing use of predetermined connectionintervals also contemplate the use of such non-predetermined connectionintervals. One way in which analyte sensor system 308 can manageconnections to multiple display devices is to allow one display deviceto maintain a communication connection with analyte sensor system 308during a given predetermined connection interval. While this allows forthe sequential connection of multiple display devices in differentpredetermined connection intervals, it limits such connections in thatno two display devices maintain a connection with analyte sensor system308 at the same time during the same predetermined connection interval,which can cause long periods between reestablishing connections with aparticular display device when multiple display devices are ultimatelyaccommodated.

Another way in which analyte sensor system 308 can manage connection tomultiple display devices is to operate utilizing a plurality of timeslots in which different classifications of device are allowed toconnect and communicate with analyte sensor system 308; for example, aconsumer timeslot, in which display devices commonly utilized by aconsumer (e.g., smart phones, smart watches, user receivers) are allowedto connect with analyte sensor system 308 one at a time, and a medicalor professional timeslot, in which display devices and/or otherproprietary or dedicated medical devices commonly utilized by a medicalprofessional are allowed to connect with analyte sensor system 308 oneat a time. Where such consumer and medical/professional timeslots areutilized, advertising parameters and protocols can be configuredsimilarly or differently for advertising availability for connectionwithin each timeslot. Such examples can further utilize multiplecorresponding whitelists, on which respective consumer ormedical/professional devices that have previously established andauthenticated secure connections with analyte sensor system 308 arelisted, to help manage connections of known or trusted display devices.In some embodiments, each such whitelist can include space for a singleentry corresponding to a single, preferred consumer device (e.g., theuser's smartphone) or a single, preferred medical/professional device(e.g., a doctor's associated health care provider device). If a user ormedical professional wants to pair a new display device not currently onthe corresponding whitelist, upon pairing of the new display device, theother display device previously on the whitelist would be removed fromthe whitelist and the newly paired display device added to the whitelistin its place in the single entry. However, when combined with therestriction that a single device can maintain a connection with analytesensor system 308 during any predetermined connection interval, displaydevices, whether consumer-class or medical/professional-class, can stillbe required to wait significant amounts of time between connections withanalyte sensor system 308.

Accordingly, several embodiments described below provide for multipledisplay devices to connect and maintain their connections concurrentlyduring the same predetermined connection interval. General conceptsdescribed below include, separately or in any combination, removing adistinction between consumer and medical/professional classifications,whitelists, and timeslots and considering each display device to be of asimilar classification, utilizing a single whitelist on which alltypes/classifications of trusted devices can be listed, and providing asingle timeslot in which one or more compatible display devices canpotentially pair and connect with analyte sensor system 308 during asame predetermined connection interval. In some embodiments, such asingle whitelist can have an increased capacity from e.g., 2 entries—oneentry for a medical/professional device and one entry for a consumerdevice—to e.g., 3 or more entries for any type or classification ofcompatible display device. Because a single timeslot is utilized forconnection and communicating with analyte sensor system 308, advertisingand connection maintenance can be handled simultaneously, or at leastconcurrently for multiple devices as occurring during the samepredetermined connection interval. Since a whitelist can still beutilized, advertising can utilize a first set of parameters for generaladvertising, e.g., to advertise to display devices not yet listed on thewhitelist, and a second set of parameters for whitelist advertising,e.g., to advertise to trusted display devices currently listed on thewhitelist. Upon establishing a connection with each of one or morecompatible display devices in the same predetermined communicationinterval, each of the one or more compatible display devices (e.g.,display devices 310) can communication with analyte sensor system 308and/or, in some cases, with one another and/or with another server(e.g., server system 334) during the same predetermined communicationinterval as described by any part of this description or as otherwiseknown. At some point during the predetermined communication interval, itcan be determined that one or more connections should be closed or anynumber of reasons. Some embodiments, rather than immediately closing oneor more connections responsive to a command or determination to closethe one or more connections, contemplate maintaining those connections,albeit potentially during or for reduced connection intervals, untilgeneral advertising concludes for a particular predetermined connectioninterval. In addition, some embodiments contemplate tuning advertisingparameters, connection parameters, and/or timeout strategies to savepower, improve responsiveness, and/or to simplify operation of one ormore devices involved. While a rogue device may hear advertisingmessages, such a rogue device would be expected to fail authenticationand, therefore, be prevented from establishing a communication sessionor being added to a whitelist. Several features of such embodiments willnow be described in more detail below.

Utilizing a Timeslot Agnostic Connection/Communication with an AnalyteSensor System

In some embodiments, a single recurring or periodic timeslot isutilized, during which a plurality of compatible display devices 310 canpotentially pair, connect and communicate with analyte sensor system308. Such a single timeslot may not provide any distinction betweenconsumer-class display devices and medical/professional-class displaydevices. Collapsing all timeslots and device classifications to a singlevariety (e.g., all compatible display devices are considered the samefor connection purposes) reduces complexity and requirements associatedwith operating, advertising and connection management protocols for alldevices involved. In addition, since only a single classification ofdisplay devices 310 is contemplated, in such embodiments, advertisingprotocols and/or parameters can also be simplified.

Utilizing a Generalized Whitelist for Connection/Communication with anAnalyte Sensor System

In some embodiments, a single or generalized whitelist is utilized, inwhich all compatible display devices 310 can potentially be listed oncean initial pairing and authentication with analyte sensor system 308 hasbeen performed. For example, where prior consumer andmedical/professional whitelists have been utilized, each having spacefor a single display device entry, in some other embodiments, a singlewhitelist for all compatible display devices 310, having 3 or moreentries for any type or classification of compatible display device 310,can be utilized. Including 3 or more entries in the whitelist allowsmultiple display devices to be whitelisted and easily reconnected asrequired for concurrent communication of analyte concentration and/orother data, for example, a user's smartphone, the user's smartwatch, andeven a third display device, for example a medical professional's healthcare provider device during a same predetermined communication interval.In some embodiments, analyte sensor system 308 can be configured toremove or delete a display device from the whitelist based on not havingreceived data from or not having transmitted data to the display devicefor a predetermined period of time or according to any other protocolfor managing a whitelist as described anywhere in this disclosure or asotherwise known.

Advertising Based on a Single Whitelist for Connection with an AnalyteSensor System

Discussion in this section will refer to FIGS. 3A-3C, FIGS. 22A and 22B,and FIG. 23. FIGS. 22A and 22B illustrate example timing diagrams 2200,2250 for advertising signaling, according to some embodiments, whileFIG. 23 illustrates an example flowchart for advertising signaling byanalyte sensor system 308, according to some embodiments.

To pair, connect and/or reconnect with analyte sensor system 308,advertising can be performed, in which advertisement messages 2202, 2204are transmitted periodically during one or more advertising intervals2206, 2208 to announce the availability of the advertising device forpairing, connection and/or reconnection during a given predeterminedconnection interval 2210. In some embodiments utilizing a singlewhitelist, first advertising messages 2202 can utilize a first set ofparameters for discovering and/or advertising to new display devices 310not currently listed on the whitelist. This first set of parameters candefine one or more of a first duration 2212 of a first advertisinginterval 2206, a first periodic interval 2214 utilized to transmitadvertising messages 2202 within first advertising interval 2206, afirst power 2216 at which first advertising messages 2202 aretransmitted, and any other parameters for transmitting first advertisingmessages 2202. Such a first set of parameters can correspond to generalor discovery advertising for devices not currently whitelisted.

Such advertising can additionally utilize second advertising messages2204 utilizing a second set of parameters for discovering and/oradvertising to display devices 310 currently listed on the whitelist.This second set of parameters can define one or more of a secondduration 2222 of a second advertising interval 2208, a second periodicinterval 2224 utilized to transmit advertising messages 2204 withinsecond advertising interval 2208, a second power 2226 at which secondadvertising messages 2204 are transmitted, and any other parameters fortransmitting second advertising messages 2204. Such a second set ofparameters can correspond to whitelist or reconnection advertising.Utilizing the first and second sets of advertising parameters forrespective first and second advertising messages 2202, 2204 allowgeneral and reconnection advertising in the same communication timeslot.

In some embodiments, first power 2216 at which general advertisingmessages 2202 are transmitted can be lower than second power 2226 atwhich reconnection advertising messages 2204 are transmitted. Forexample, a user attempting to pair and connect a new display device 310,e.g., a smartphone or smartwatch, is likely to have the new displaydevice 310 disposed in close proximity to analyte sensor system 308(e.g., within a few feet). Such general advertising need not utilize amaximum, e.g., 30-meter, transmission power at least due to the closeproximity of new display device 310 and analyte sensor system 308. Bycontrast, it can be desirable to keep whitelisted display devices 310connected or to reconnect them, even when those whitelisted devices area significantly greater distance from analyte sensor system 308, e.g., asmartphone left on a table while the user walks into another roommomentarily. However, the present disclosure is not so limited and firstpower 2216 and/or second power 2226 can be configurable orreconfigurable to have any suitable absolute values and/or any suitablerelative values with respect to the other.

In some embodiments, first duration 2212 of first advertising interval2206 and/or first periodic interval 2214 utilized to transmitadvertising messages 2202 within first advertising interval 2206 forgeneral advertising can be different from second duration 2222 of secondadvertising interval 2208 and/or second periodic interval 2224 utilizedto transmit advertising messages 2204 within second advertising interval2208 for reconnection advertising. In addition, a first frequency ofoccurrence of first advertising interval 2206 can be different from asecond frequency of occurrence of second advertising interval 2208. Forexample, analyte concentration data can be measured, processed orcommunicated every 30 seconds or every minute. Accordingly, in suchembodiments, the second frequency of occurrence of second advertisinginterval 2208 can correspond to this timeframe and associated frequencyof occurrence, e.g., every 30 seconds or every minute. However, it maynot be necessary or desirable to attempt to “discover” new displaydevices not currently on the whitelist, that may or may not be present,on such short intervals, e.g., at the second frequency of occurrence.Accordingly, the first frequency of occurrence of first advertisinginterval 2206, associated with general advertising, can be lower thanthe second frequency of occurrence of second advertising interval 2208,associated with reconnection advertising. Utilizing a longer intervalbetween general advertising intervals can save power within analytesensor system 308 by reducing a number of times or a frequency ofgeneral advertising.

In addition, in some embodiments, analyte sensor system 308 and/or oneor more already connected display devices 310 can further comprise abutton or other user input that allows a user to initiate a generaladvertisement session on demand, for example, when the user wants topair and connect a new display device 310 to analyte sensor system 308,e.g., the user's smartphone or smartwatch.

Description now turns to flowchart 2300 of FIG. 23, describingadvertising operations of, for example, analyte sensor system 308,according to some embodiments. Block 2302 includes transmitting one ormore first advertising messages utilizing a first set of parametersduring a predetermined communication interval if a whitelist ofpreviously authenticated devices has at least one unfilled entry. Forexample, during predetermined connection interval 2210, based on nodisplay devices being listed on such a whitelist or based on thewhitelist having at least one unfilled entry, analyte sensor system 308can be configured to transmit one or more first advertising messages2202 utilizing a first set of parameters, for example, defining one ormore of first duration 2212 of first advertising interval 2206, firstperiodic interval 2214 utilized to transmit first advertising messages2202 within first advertising interval 2206, first power 2216 utilizedto transmit first advertising messages 2202, and any other parametersfor such advertising. Such a first set of parameters can correspond todiscovery, or general advertising for devices not currently listed onthe whitelist.

In some embodiments, when analyte sensor system 308 is first powered up,analyte sensor system 308 can be configured to perform a pairingadvertisement in which duration 2212 of first advertising interval 2206is e.g., 15 minutes or less, although the present disclosure is not solimited, and duration 2212 of first advertising interval 2206 can be anysuitable interval. Because of the shorter advertising interval comparedto some other potential implementations, such an advertisement may beconsidered a fast pairing advertisement. In such embodiments, firstperiodic interval 2214 can be, e.g., 1024 msec, although the presentdisclosure is not so limited, and first periodic interval 2214 can beany suitable interval. In such embodiments, the “fast pairingadvertisement” mode ends upon any display device “completing,” e.g.,successfully pairing and authenticating with analyte sensor system 308.Upon expiration of first advertising interval 2212 or the completion ofany display device, advertising can follow any advertising protocoldescribed herein or otherwise known.

Block 2304 includes not transmitting the one or more first advertisingmessages during the predetermined communication interval if thewhitelist does not have at least one unfilled entry. For example, insome embodiments, if there are no entries available on the whitelistthere can be no room for an additional device to connect. Accordingly,in such embodiments, analyte sensor system 308 can be configured to notperform general advertising to save power.

Block 2306 includes transmitting one or more second advertising messagesutilizing a second set of parameters during the predeterminedcommunication interval if the whitelist lists at least one device. Forexample, during predetermined connection interval 2210, based on atleast one display device 310 being listed on the whitelist, analytesensor system 308 can be configured to transmit one or more secondadvertising messages 2204 utilizing a second set of parameters forexample, defining second duration 2222 of second advertising interval2208, second periodic interval 2224 utilized to transmit secondadvertising messages 2204 within second advertising interval 2208,second power 2226 utilized to transmit advertising messages, and anyother parameters for such advertising. Such a second set of parameterscan correspond to reconnection advertising for display devices currentlylisted on the whitelist.

Block 2308 includes not transmitting the one or more second advertisingmessages during the predetermined communication interval if thewhitelist does not currently list any devices or if all devicescurrently listed on the whitelist connected to the analyte sensor systemresponsive to the one or more first advertising messages. For example,if there are no currently whitelisted devices, there would not be a needfor reconnection advertising. In some embodiments, for example as shownin FIG. 22B, analyte sensor system 308 can transmit one or more generaladvertising messages (e.g., 2202) utilizing the first set of parametersbefore transmitting one or more reconnection advertising messages (e.g.,2204) utilizing the second set of parameters in the same predeterminedconnection interval. In such embodiments, performing general advertisingfor new devices before performing reconnection advertising can alsoallow currently whitelisted devices to reconnect with analyte sensorsystem 308 during the general advertising interval (e.g., 2206) as wellas allow the discovery and paring of additional new display devicesduring the general advertising interval (e.g., 2206) in the samepredetermined connection interval. Moreover, where all such whitelisteddevices are in range and have reconnected with analyte sensor system 308during general advertising interval 2206, analyte sensor system 308 canbe configured to delay or not transmit the subsequent reconnectionadvertisements 2204 during predetermined connection interval 2210,thereby allowing analyte sensor system 308 to further save power.

In some embodiments, for example as shown in FIG. 22A, analyte sensorsystem 308 can transmit one or more general advertising messages (e.g.,2202) utilizing the first set of parameters after transmitting one ormore reconnection advertising messages (e.g., 2204) utilizing the secondset of parameters. In such embodiments, performing general advertisingfor new devices after performing reconnection advertising for currentlywhitelisted devices can allow for the discovery and pairing ofadditional display devices after connection of currently whitelisteddisplay devices. This is in contrast to some prior embodiments whereadvertisement would not continue after connecting a single whitelisteddisplay device because the prior consumer or medical/professionalwhitelist would not have had another entry for additionally whitelistinga further display device and because such prior embodiments onlyprovided for connection of a single display device with analyte sensorsystem 308 during a particular predetermined connection interval.

Block 2310 includes establishing a first communication session betweenan analyte sensor system and a first device and a second communicationsession between the analyte sensor system and a second device based onat least one of the first advertising messages and the secondadvertising messages. For example, as illustrated in FIGS. 22A and 22B,based on at least one of first advertising messages 2202 and secondadvertising messages 2204, analyte sensor system 308 can be configuredto establish a first communication session with a first device (e.g.,display device 310 a of FIG. 3C) and a second communication session witha second device (e.g., display device 310 b of FIG. 3C).

Block 2312 includes transmitting analyte concentration data to the firstdevice and to the second device utilizing at least one of the firstcommunication session and the second communication session during thepredetermined communication interval. For example, as illustrated inFIGS. 22A and 22B, utilizing at least one of the first communicationsession and the second communication session during predeterminedcommunication interval 2210, analyte sensor system 308 can be configuredto transmit analyte concentration data to first device 310 a and tosecond device 310 b. Accordingly, both the first and secondcommunication sessions can be kept open concurrently.

Communicating/Backfilling Data During a Communication Session

In some embodiments, where a first display device 310 a (e.g., asmartphone, see FIG. 3C) and a second display device 310 b (e.g., asmartwatch, see FIG. 3C) are both connected to analyte sensor system 308during the same predetermined connection interval, for example asdescribed above in connection with at least FIGS. 22A-23, analyte sensorsystem 308 can transmit data to and/or receive data from first displaydevice 310 a and second display device 310 b in any manner describedanywhere in this description or as otherwise known. In some embodiments,alarm data may also be transmitted by analyte sensor system 308 alongwith sensor data to one or both of display devices 310 a, 310 b.

In some embodiments, upon establishing a connection with analyte sensorsystem 308, connected display devices 310 a, 310 b can be configured todisplay an icon, for example on display 345, indicating display device310 a, 310 b is connected. In addition, analyte sensory system 308 cantransmit one or more alarm indications to first display device 310 a forprocessing and second display device 310 b can be configured to displayan associated alarm notification to the user based on receiving anindication of the alarm from first display device 310 a. In otherembodiments, one or more alarm indications can be transmitted fromanalyte sensor system 308 directly to second display device 310 b andsecond display device 310 b can be configured to display an associatedalarm notification to the user based on receiving and/or processing thealarm.

In some embodiments, multiple display devices 310 a, 310 b can beconcurrently connected to analyte sensor system 308 and can generallycommunicate data between analyte sensor system 308 and display devices310 a, 310 b. However, there can be instances where one of displaydevices 310 a, 310 b are out of range or otherwise unavailable for aperiod of time during a session in which analyte sensor system 308 ismeasuring, collecting, processing and/or generating data fortransmission to one or both of connected display devices 310 a, 310 b.Such a period of time can be minutes, hours or even days. In suchinstances, it can be desirable to be able to backfill data, stored byone of the display devices 310 a, 310 b or by analyte sensor system 308,to the unavailable display device once the unavailable display devicebecomes available for communication again.

For example, a first display device 310 b can be configured to receiveand store data related to an analyte concentration monitoring session,for example analyte concentration measurements, indications of foodintake, indications of exercise or other user activity while a seconddisplay device 310 a is out of range or otherwise unavailable to firstdisplay device 310 b and/or analyte sensor system 308 for a period oftime. In some embodiments, analyte sensor system 308 can also oralternatively be configured to store such data during this period oftime. First display device 310 b and/or analyte sensor system 308 canthen be configured to transmit all or a subset of that stored data tosecond display device 310 a responsive to second display device 310 asubsequently reentering communication range or otherwise becomingavailable for communication with first display device 310 b and/oranalyte sensor system 308. Such transmission/backfilling of data can becommunicated utilizing any wireless communication protocol, e.g., Wi-Fi,BLE, Bluetooth, cellular, NFC or any other communication protocoldescribed in this disclosure or otherwise known. In some embodiments,such backfilling of data to display device 310 a can be executedresponsive to display device 310 a transmitting a request for the dataultimately backfilled. In some embodiments, such backfilling of data todisplay device 310 a can be executed responsive to one or both ofdisplay device 310 b and analyte sensor system 308 detecting orotherwise determining that display device 310 a has reenteredcommunication range.

For example, and not limitation, a user may wear display device 310 b(e.g., as a smartwatch) and analyte sensor system 308 during a run butthe user may not take display device 310 a (e.g., as a smartphone) alongon the run. During the run and/or during any time interval displaydevice 310 a is out of range or otherwise unavailable, display device310 b can receive and store the data related to an analyte concentrationmonitoring session. In some embodiments, analyte sensor system 308 canalso or alternatively be configured to store the data during the timeinterval. Upon returning from the run and/or upon display device 310 areentering communication range or otherwise becoming available forcommunication with display device 310 b and/or analyte sensor system308, display device 310 b and/or analyte sensor system 308 can beconfigured to transmit (e.g., backfill) all or a subset of that storeddata to display device 310 a responsive to display device 310 asubsequently reentering communication range or otherwise becomingavailable for communication with display device 310 b and/or analytesensor system 308. In some embodiments, upon reentering communicationrange or otherwise becoming available for communication with displaydevice 310 b and/or analyte sensor system 308, display device 310 a canbe configured to transmit a request for all or a subset of that storeddata. For example, such a request can include one or more timestamps, orindications of such timestamps, corresponding to one or more data setsof missed data to be backfilled. Display device 310 a can also beconfigured to provide the same receipt, storage andtransmission/backfilling of data with respect to display device 310 b ina reverse arrangement. Display devices 310 a, 310 b can be similarlyconfigured to receive or generate, store and transmit/backfill any typeof data to analyte sensor system 308 in related arrangements. In someembodiments, each of display devices 310 a, 310 b and analyte sensorsystem 308 can be configured to store and subsequently transmit/backfill3 hours, 6 hours, 12 hours, 24 hours or any other amount of data to oneor both of the other devices, and/or to another server (e.g., serversystem 334 in FIG. 3A).

In some cases, smartwatch manufacturers have considered that, when suchsmartwatches are not being worn by a user, notifications mayautomatically revert to the user's connected smartphone. However, theability to acknowledge notifications, e.g., halt alert sequences withoutgoing to the smartphone, can be a desired direct-to-watch experience toprovide to the user, where some previous implementations would merelysend such alerts and/or sequences from analyte sensor system 308 to thesmartphone.

The present disclosure contemplates that analyte sensor system 308 mayalso communicate such alerts, alarms and/or sequences, e.g., glucosealerts, directly to a smartwatch 310 b when a connected smartphone 310 ais not present. Some embodiments may utilize built-in notificationde-duplication logic to prevent the same alert from being displayed onboth smartwatch 310 b and connected smartphone 310 a. Otherwise,smartwatch 310 b and connected smartphone 310 a may each generate aninstance of the same alert. In some embodiments, an algorithm can beutilized by one or more of analyte sensor system 308 and smartwatch 310b to detect and/or otherwise determine the absence of connectedsmartphone 310 a and responsively carry out a direct-to-watch alertingoperation.

In some embodiments, setting up such a direct-to-watch implementationmay include a new pairing operation between a new analyte sensor system308 and one or both of the user's smartwatch 310 b and the user'ssmartphone 310 a. In some embodiments, certain control features may bemanaged and/or controlled by the user via smartphone 310 a, for examplethe ability of a user to input commands to start and/or stop sensoracquisition of analyte data, initial pairing with a new transmitter(e.g., analyte sensor system 308) and changes to alert settings and/orthresholds. In some embodiments, smartwatch 310 b can be configured todisplay a continuous glucose monitored glucose value, an arrowindicating a direction, trend or forecast of a monitored glucose value,and/or a trend graph of the monitored glucose value when smartphone 310a is out of range of one or both of analyte sensor system 308 andsmartwatch 310 b, thereby providing a classic smartwatch experience, butwith data pulled from and/or transmitted directly from analyte sensorsystem 308 to smartwatch 310 b. Such embodiments may provide morereliable electronic glucose value updates on smartwatch 310 b for a moreup-to-date user experience. In some embodiments, alerts and/or alarmscan be displayed by smartwatch 310 b and/or acknowledged by the user viainput to smartwatch 310 b when smartphone 310 a is out of range of oneor both of smartwatch 310 b and analyte sensor system 308. Such alertsand/or alarms may comprise any one or more of visual, auditory andhaptic notifications.

In some embodiments, an invitation screen on a continuous glucosemonitoring app configured to run on the user's connected smartphone 310a may be configured to inform the user of the availability status ofsuch direct-to-watch features based at least in part on detection of oneor both of an analyte sensor system 308 and a smartwatch 310 b that areeach configured to support such direct-to-watch features. Such an appmay also provide one or more setup screens to support the setup of newfeatures on connected smartwatch 310 b and/or to support pairing ofanalyte sensor system 308 with smartwatch 310 b, for example, when a newanalyte sensor system 308 is first activated. In some embodiments,analyte sensor system 308 can be configured to allow for direct-to-watchoperation while also retaining display, alerting and/or alarmingfunction on connected smartphone 310 a and/or on another display device.

Description now turns to flowchart 2400 of FIG. 24A, describingbackfilling by analyte sensor system 308 to a previously but temporarilyunavailable display device 310 a, according to some embodiments. Block2402 includes establishing a first communication session with a firstdisplay device and a second communication session with a second displaydevice, the second display device becoming unavailable for communicationwith the first device and with the analyte sensor system for a timeperiod subsequent to establishing the second communication session. Forexample, analyte sensor system 308 can be configured to establish afirst communication session with first display device 310 b (e.g., asmart watch) and a second communication session with second displaydevice 310 a (e.g., a smart phone), for example as previously describedin connection with FIGS. 22A-23. Second display device 310 a can becomeunavailable for communication with first device 310 b and with analytesensor system 308 for a time period subsequent to establishing thesecond communication session as described above.

Block 2404 includes transmitting analyte sensor data to the firstdisplay device via the first communication session. For example, analytesensor system 308 can be configured to transmit analyte sensor data tofirst display device 310 b (e.g., the smart watch) via the firstcommunication session.

Block 2406 includes storing the analyte sensor data at least during thetime period. For example, analyte sensor system 308 can be configured tostore the analyte sensor data at least during the time period thatsecond display device 310 a (e.g., the smartphone) is unavailable.

Block 2408 includes receiving a request for the stored analyte sensordata from the second display device upon the second display devicebecoming available for communication with the analyte sensor systemafter the time period. For example, analyte sensor system 308 can beconfigured to receive a request for the stored analyte sensor data fromsecond display device 310 a upon second display device 310 a becomingavailable for communication with analyte sensor system 308 after thetime period.

Block 2410 includes transmitting the stored analyte sensor data to thesecond device utilizing the second communication session responsive tothe request. For example, analyte sensor system 308 can be configured totransmit the stored analyte sensor data to second device 310 a (e.g.,the smartphone) utilizing the second communication session responsive toreceiving the request from second device 310 a.

Description now turns to flowchart 2450 of FIG. 24B, describingbackfilling by display device 310 b to a previously but temporarilyunavailable display device 310 a, according to some embodiments. Block2452 includes establishing a first communication session between a firstdisplay device and an analyte sensor system and a third communicationsession between the first display device and a second display device,the second display device having established a second communicationsession with the analyte sensor. For example, a display device such asdisplay device 310 b can be configured to establish a firstcommunication session with analyte sensor system 308 and a thirdcommunication session with display device 310 a, display device 310 ahaving established a second communication session with analyte sensor308.

Block 2454 includes receiving analyte sensor data from the analytesensor system via the first communication session, wherein the seconddisplay device becomes unavailable for communication with the firstdevice and with the analyte sensor system for a time period subsequentto establishment of the second communication session. For example,display device 310 b can be configured to receive analyte sensor datafrom analyte sensor system 308 via the first communication session.Display device 310 a becomes unavailable for communication with displaydevice 310 b and with analyte sensor system 308 for a time periodsubsequent to establishment of the second communication session.

Block 2456 includes storing the analyte sensor data at least during thetime period. For example, display device 310 b can be configured tostore the analyte sensor data at least during the time period displaydevice 310 a is unavailable.

Block 2458 includes receiving a request for the stored analyte sensordata from the second display device upon the second device becomingavailable for communication over the third communication session afterthe time period. For example, first display device 310 b can beconfigured to receive a request for the stored analyte sensor data fromsecond display device 310 a upon second display device 310 a becomingavailable for communication over the third communication session afterthe time period.

Block 2460 includes transmitting the stored analyte sensor data to thesecond device utilizing the third communication session responsive tothe request. For example, display device 310 b can be configured totransmit the stored analyte sensor data to display device 310 autilizing the third communication session responsive to receiving therequest from display device 310 a.

Description now turns to flowchart 2480 of FIG. 24C, describingreceiving backfill data by a previously but temporarily unavailabledisplay device 310 a, according to some embodiments. Block 2482 includesestablishing a first communication session with an analyte sensor systemand a second communication session with a first display device. Forexample, display device 310 a can be configured to establish a firstcommunication session with analyte sensor system 308 and a secondcommunication session with display device 310 b.

Block 2484 includes becoming unavailable for communication with thefirst device and with the analyte sensor system for a time periodsubsequent to establishment of the first communication session. Forexample, display device 310 a can become unavailable for communicationwith display device 310 b and with analyte sensor system 308 for a timeperiod subsequent to establishment of the first communication session.

Block 2486 includes transmitting a request to at least one of the firstdisplay device and the analyte sensor system upon becoming available forcommunication with the at least one of the first device and the analytesensor system after the time period. For example, display device 310 acan be configured to transmit a request to at least one of displaydevice 310 b and analyte sensor system 308 upon becoming available forcommunication with the at least one of first device 310 b and analytesensor system 308 after the time period.

Block 2486 includes receiving analyte sensor data, previously stored bythe at least one of the first display device and the analyte sensorsystem during the time period, over at least one of the firstcommunication session and the second communication session based on therequest. For example, display device 310 a can be configured to receiveanalyte sensor data, previously stored by at least one of display device310 b and analyte sensor system 308 during the time period displaydevice 310 a was unavailable, over at least one of the firstcommunication session and the second communication session based on therequest.

Closing Connections with an Analyte Sensor System

In some circumstances analyte sensor system 308 may wish to close anexisting connection with a connected display device 310. Rather thanimmediately closing the existing connection during a predeterminedcommunication interval, analyte sensor system 308 can be configured todelay closing of the existing connection until after completion ofgeneral advertising, e.g., advertising which utilizes the first set ofparameters for transmission of advertising messages. This can provideseveral benefits.

For example, some display devices, e.g., some smartphones, areconfigured to continuously monitor for general advertising when they arenot associated with an established communication session with anotherdevice, e.g., with an analyte sensor system. If an establishedcommunication session between such a display device and the analytesensor system is terminated while the analyte sensor system isperforming general advertising, the display device may immediately beginmonitoring for general advertising and may undesirably reestablish a newcommunication session with the analyte sensor system in the samepredetermined connection interval in which the prior communicationsession was terminated. By keeping such a communication session open fora period of time after it is identified for closing, e.g., until aftergeneral advertising has completed, such undesirable reestablishing of anew communication session in the same predetermined connection intervalin which the prior communication session was terminated can beprevented. In some cases, medical display devices can also be configurednot to monitor for general advertisements until the next predeterminedconnection interval.

In some embodiments, analyte sensor system 308 can be configured toclose one or more connections, e.g., communication sessions, responsiveto a mode of analyte sensor system 308 changing. For example, analytesensor system 308 can transition from a mode where a glucose monitoringsession, e.g., measuring and/or transmitting glucose data, is currentlyin progress to a mode where the glucose monitoring session is no longerin progress. In some embodiments, this state change can be initiatedresponsive to user input from one 310 a of a plurality of displaydevices 310 a, 310 b that are simultaneously connected to analyte sensorsystem 308. Such a mode or state transition of analyte sensor system 308can be problematic for a display device, e.g., display device 310 b,that expects the mode or state of analyte sensor system 308 to remainunchanged while that display device 310 b is connected to analyte sensorsystem 308. By closing all connections to display devices, e.g., displaydevice 310 b, other than the particular display device that caused thestate change, e.g., display device 310 a, all connected display devices310 a, 310 b can have an accurate understanding of the mode or state ofanalyte sensor system 308 for the duration of their connection.

In some embodiments, rather than closing a connection for which adetermination to close has been made or for which a close request hasbeen received, the connection can be kept alive through the transmissionof periodic heartbeat signals configured to notify analyte sensor system308 that a connected display device 310 is still using or still intendsto use the connection. In some embodiments, the heartbeat signals can betransmitted periodically by connected display device 310 according to afirst interval before a connection close request or close determination,while the heartbeat signal can be adjusted such that it is transmittedby connected display device 310 according to a second interval greaterthan the first interval after the connection close request. Accordingly,one or both of analyte sensor system 308 and the connected displaydevice 310 can negotiate, calculate or otherwise determine the firstinterval and/or the second interval.

In some embodiments, analyte sensor system 308 can be configured toclose a connection with a particular display device 310 responsive tothe connection being determined inactive for a predetermined period oftime (e.g., 3 seconds). In such embodiments, one or more of thefollowing conditions can indicate that a connection is active: thedisplay device on the connection is authenticated, the display device onthe connection completes a BLE pairing process, the display device onthe connection completes a BLE bonding process, analyte sensor system308 transmits or receives an opcode over the connection, analyte sensorsystem 308 transmits a data packet over the connection, communicationover the connection is blocked by another connected display deviceexecuting an opcode (e.g., a connection will not timeout while thedisplay device is waiting for service from analyte sensor system 308),receipt of a heartbeat signal configured to notify analyte sensor system308 that a connected display device is still using or still intends touse the connection, or any other suitable operation that utilizes theconnection.

In some embodiments, one or more connection parameters (e.g., thepredetermined timeout period described above, the intervals and/or othercharacteristics of heartbeat signals, etc.) can be negotiated,determined, adjusted or otherwise established or modified by analytesensor system 308 and a connected display device 310 based on one ormore factors. For example, a first set of connection parameters can beutilized for active connections, a second set of connection parameterscan be utilized for connections providing data streaming, and/or a thirdset of connection parameters can be utilized for connections that havebeen identified for closure but are being kept alive as describedthroughout this description.

Description now turns to flowchart 2500 of FIG. 25, describing the delayor prevention of the closure of communication connections for which adetermination has been made that the communication connections should beclosed, according to some embodiments. Block 2502 includes determiningthat a first communication session between an analyte sensor system anda display device is to be closed. For example, analyte sensor system 308can be configured to determine that a first communication session with adisplay device, e.g., one or both of display device 310 a, 310 b, is tobe closed.

Block 2504 includes delaying the closing of the first communicationsession at least until after advertising messages have been transmitted.For example, analyte sensor system 308 can be configured to delay theclosing of the first communication session at least until afteradvertising messages 2202 (see FIG. 22A, B) have been transmitted.

In some embodiments, an additional block 2506 can include, responsive tothe determining, preventing the first communication session from beingclosed based on receiving a plurality of heartbeat signals over thefirst communication session after the determining. For example, in someembodiments, analyte sensor system 308 can be further or alternativelyconfigured to, responsive to determining that the first communicationsession is to be closed, prevent the first communication session frombeing closed based on receiving a plurality of heartbeat signals fromthe display device, e.g., one or both of display device 310 a, 310 b,over the first communication session after the determination has beenmade. In some such embodiments, display devices 310 a, 310 b can preventtheir communication sessions from being closed, despite analyte sensorsystem 308 having previously determined the communication sessionsshould be closed, at least during general advertising of a particularpredetermined connection interval, by sending such heartbeat signals.

Data Logging Health Care Provider Devices

In some embodiments, it may be desirable for a health care provider, forexample a user's doctor, to be able to access analyte concentration dataof the user to aid in medical treatment. Accordingly, severalembodiments that may utilize heath care provider device 150, as brieflyintroduced in connection with FIG. 1A, are described below.

FIG. 26 depicts system 2602, which includes examples of additionalaspects of the present disclosure that can be used in connection withany analyte sensor system described herein. As illustrated in FIG. 26,system 2602 can include health care provider (HCP) device 150, which isconfigured to be utilized by health care providers to download, track,log, and/or otherwise analyze data provided by one or more analytesensor systems, for example analyte sensor system 2608. Although severalfeatures of HCP device 150 are described below, the present disclosurecontemplates that HCP device 150 can comprise additional, fewer oralternative elements, features and/or functionality to thosespecifically described.

As shown, HCP device 150 can include a processor/microprocessor 2635 forprocessing, analyzing and/or managing sensor data ultimately receivedfrom analyte sensor system 2608. HCP device 150 can include display2645, storage 2625, analyzing programs 2630, and real time clock 2650for displaying, storing, and analyzing sensor data. HCP device 150 canfurther include a radio unit or transceiver 2620 coupled to otherelements of HCP device 150 via connectivity interface 2615 and/or a bus.Transceiver 2620 can employ a communication protocol for receivingsensor data from and sending requests, instructions, and/or data toanalyte sensor system 2608. Storage 2625 can also be used for storing anoperating system for HCP device 150 and/or a custom (e.g., proprietary)application designed for analyzing sensor data ultimately downloadedand/or received from analyte sensor system 2608. Storage 2625 can be asingle memory device or multiple memory devices and can be a volatile ornon-volatile memory for storing data and/or instructions for softwareprograms and applications. The instructions can be executed by processor2635 to control and manage the operations of one or more components ofHCP device 150.

Connectivity interface 2615 interfaces HCP device 150 to communicationmedium 305, such that HCP device 150 can be communicatively coupled toanalyte sensor system 2608 via communication medium 305. Transceiver2620 of connectivity interface 2615 can include multiple transceivermodules operable on different wireless standards. Transceiver 2620 canbe used to receive analyte data and, in some embodiments, associatedcommands and messages from analyte sensor system 2608. Additionally,connectivity interface 2615 can in some cases include additionalcomponents for controlling radio and/or wired connections, such asbaseband and/or Ethernet modems, audio/video codecs, and so on.

Storage 2625 can include volatile memory (e.g. RAM) and/or non-volatilememory (e.g. flash storage), can include any of EPROM, EEPROM, cache, orcan include some combination/variation thereof. In various embodiments,storage 2625 can store user input data and/or other data collected byHCP device 150. Storage 2625 can also be used to store volumes ofanalyte data received from analyte sensor system 2608 for analyzation.Additionally, storage 2625 can store analyzing programs 2630 that, whenexecuted using processor 2635, for example, analyze sensor dataultimately received from analyte sensor system 2608 and can beconfigured to generate one or more patient reports corresponding to ananalysis of the sensor data.

In various embodiments, a user can interact with analyzing programs 2630via GUI 2640, which can be provided by display 2645 of HCP device 150.

In various embodiments, HCP device 150 can further comprise anelectromagnet 2695 configured to generate a unique electromagneticsequence and/or signal configured to wake one or more portions of ananalyte sensor system 2608 from a low-power, sleep, or shelf mode inpreparation for transmission of logged data from analyte sensor systemto HCP device 150, for example after a data logging session for analytesensor system 2608 is complete. A bus (not shown here) can be used tointerconnect the various elements of health care provider device 150 andtransfer data between these elements.

As illustrated in FIG. 26, system 2602 can further include analytesensor system 2608 communicatively couplable to HCP device 150 viacommunication medium 305. As shown, analyte sensor system 2608 caninclude substantially the same elements, having substantially the samefunctionality, as analyte sensor system 308 as previously described inconnection with FIG. 3B, however, further including a magnetic sensor2690 configured to generate a signal configured to wake one or morecomponents of analyte sensor system 2608 (e.g., FIG. 4) responsive toreceiving a predetermined signal from electromagnet 2695 of HCP device150 in preparation for transmission of logged data from analyte sensorsystem to HCP device 150.

Several example operations of HCP device 150 and analyte sensor system2608 will be now be described below. In some embodiments, a patient canwear analyte sensor system 2608, which can measure analyteconcentrations of the patient (e.g., utilizing sensor 375 and sensormeasurement circuitry 370) and log those analyte concentrations (e.g.,utilizing storage 365). In some embodiments, analyte sensor system 2608may not immediately transmit logged analyte concentrations to a displaydevice or to HCP device 150. Accordingly, in such embodiments, thepatient may not be immediately notified of the analyte concentrations.Rather, analyte sensor system 2608 can be configured to log analyteconcentrations for an entire session (e.g., 1 day, 10 days, etc.) and,after the data-collecting session has ended, analyte sensor system 2608can be configured to revert to a low-power, sleep or shelf mode untilawakened by HCP device 150 for transferring the logged analyteconcentrations and/or other data to HCP device 150 and/or to anotherserver (e.g., server system 334 of FIG. 3A) for subsequent analyzation.

After the data-collecting session has ended, analyte sensor system 2608can be mailed or otherwise physically delivered to the health careprovider (e.g., a doctor or pharmacist), where the logged data can bedownloaded, analyzed and one or more reports of the analysis can begenerated by HCP device 150.

In some embodiments, the health care provider can be providing care tomore than one patient and, therefore, multiple analyte sensor systems,such as system 2608, can be deployed to multiple patients at a giventime. Accordingly, HCP device 150 can have access to a range oftransmitter identifications (IDs) corresponding to all or a subset ofthe analyte sensor systems currently deployed.

Upon receipt by the health care provider, analyte sensor system 2608 canbe woken from its low-power, sleep or shelf mode by HCP device 150. HCPdevice 150 can be configured to generate a signal having a uniquesequence configured to wake one or more portions of an analyte sensorsystem 2608 from the low-power, sleep, or shelf mode. For example, HCPdevice 150 can be configured to cause electromagnet 2695 to generatesuch an electromagnetic wake signal. Alternatively, HCP device 150 canbe configured to cause transceiver 2620 to transmit such a wake signal.

Responsive to receiving the wake signal, analyte sensor system 2608 canbe configured to wake from the low-power, sleep or shelf mode. Forexample, magnetic sensor 2690 can be configured to generate a wakesignal configured to wake one or more components of analyte sensorsystem 2608 (see, e.g., FIG. 4). Alternatively, transceiver 360,connectivity interface 355 or processor/microcontroller 380 can beconfigured to generate the wake signal.

Upon waking, analyte sensor system 2608 can be configured to transmit anindication of its corresponding transmitter ID to HCP device 150 in oneor more beacon or other messages. In some embodiments, analyte sensorsystem 2608 can be configured to only pair and communicate with HCPdevice 150 after the data logging session has ended. Accordingly,responsive to receiving the transmitter ID, HCP device 150 can comparethe received transmitter ID to the range of transmitter IDscorresponding to the analyte sensor systems currently deployed. Based ona determination that the received transmitter ID is within the range oftransmitter IDs currently deployed, HCP device 150 and analyte sensorsystem 2608 can pair with one another and establish a wirelessconnection according to any pairing protocol described herein or anyother suitable pairing protocol. HCP device 150 can then download thelogged analyte concentration data and/or other data from analyte sensorsystem 2608. The logged analyte concentration data and/or other data canbe stored locally in storage 2625 and/or can be stored remotely inanother server, for example, server system 334 of FIG. 3A. The loggedanalyte concentration data and/or other data can then be analyzed, andone or more patient reports can be generated based thereon.

In some embodiments, the above session logging, end-of-sessiondownloading and subsequent analyzation of downloaded data for reportgeneration can be repeated or concurrently carried out for a pluralityof analyte sensor systems, for example in a bulk upload operation.

Description now turns to flowchart 2700 of FIG. 27A, describingoperations of, for example, HCP device 150, as previously described inconnection with FIG. 26. Block 2702 includes transmitting a wake signalto an analyte sensor system. For example, HCP device 150 can utilizeelectromagnet 2695 and/or transceiver 2620 to generate a uniqueelectromagnetic sequence and/or signal configured to wake one or moreportions of an analyte sensor system 2608 from a low-power, sleep, orshelf mode.

Block 2704 includes receiving a transmitter ID corresponding to theanalyte sensor system. For example, HCP device 150 can receive anindication of the transmitter ID corresponding to analyte sensor system2608 from analyte sensor system 2608 in one or more beacon messages orother messages.

Block 2706 includes comparing the received transmitter ID to a range oftransmitter IDs corresponding to analyte sensor systems currentlydeployed. For example, HCP device 150 may have prior knowledge of therange of transmitter IDs corresponding to analyte sensor systemscurrently deployed and can be configured to compare the receivedtransmitter ID from analyte sensor system 2608 to that range todetermine whether analyte sensor system 2608 is one of those deployedsystems.

Block 2708 includes establishing a wireless connection with the analytesensor system based on a determination that the received transmitter IDis within the range of transmitter IDs corresponding to currentlydeployed analyte sensor systems. For example, HCP device 150 and analytesensor system 2608 can pair with one another and establish a wirelessconnection according to any pairing protocol described herein or anyother suitable pairing protocol.

Block 2710 includes receiving at least analyte concentration data loggedby the analyte sensor system during a prior sensor session. For example,HCP device 150 can download the logged analyte concentration data and/orother data from analyte sensor system 2608.

Block 2712 includes generating one or more reports based on at least thelogged analyte concentration data. For example, HCP device 150 cananalyze the logged analyte concentration data and/or other data, and oneor more patient reports can be generated based thereon.

Description now turns to flowchart 2750 of FIG. 27B, describingoperations of, for example, analyte sensor system 2608, as previouslydescribed in connection with FIG. 26. Block 2752 includes receiving awake signal from a heath care provider device. For example, analytesensor system 2608 can receive a unique electromagnetic sequence and/orsignal configured to wake one or more portions of an analyte sensorsystem 2608 from a low-power, sleep, or shelf mode. The sequence orsignal can be generated by electromagnet 2695 and/or transceiver 2620 ofHCP device 150 and received by magnetic sensor 2690 and/or transceiver360, respectively.

Block 2754 includes transmitting a transmitter ID corresponding to theanalyte sensor system. For example, analyte sensor system 2608 cantransmit an indication of the transmitter ID corresponding to analytesensor system 2608 in one or more beacon messages or other messages.

Block 2756 includes establishing a wireless connection with the healthcare provider device based on the transmitted transmitter ID beingwithin the range of transmitter IDs corresponding to currently deployedanalyte sensor systems. For example, HCP device 150 and analyte sensorsystem 2608 can pair with one another and establish a wirelessconnection according to any pairing protocol described herein or anyother suitable pairing protocol.

Block 2758 includes transmitting at least logged analyte concentrationdata to the health care provider device. For example, HCP device 150 candownload the logged analyte concentration data and/or other data fromanalyte sensor system 2608. One or more reports can be generated basedon at least the logged analyte concentration data from the analytesensor system.

Delaying Processing of Logged Analyte Data Until after a Session isComplete

In some embodiments, it may be desirable to sample analyteconcentrations (e.g., blood glucose concentrations) periodically, logthe raw data, and delay processing and/or conversion of the raw datauntil a sensor session has concluded (e.g., after a 1- or 10-day sensorsession, which can correspond to an intended usable life of the analytesensor system). Post-processing and/or other conversion of the raw datato estimated glucose values can then be carried out after the sensorsession has concluded to, for example, determine the nature of thediabetes of the patient (e.g., Type 1, Type 2). By delaying theconversion of the raw data to estimated glucose values, computationaland operational burden on the analyte sensor system (e.g., any analytesensor system described herein) can be greatly reduced, since alarmsand/or alerts would not be generated in real-time or near real-time(i.e., when the user is using the analyte sensor system). In suchembodiments, the analyte sensor system would essentially function as adata logger during the sensor session.

Flowchart 2800 of FIG. 28 describes example operations of an analytesensor system, for example analyte sensor system 308 or any otheranalyte sensor system described herein, according to such data loggingand conversion/processing delaying embodiments. Block 2802 includesperiodically collecting raw data from an analyte sensor for a durationof a sensor session. For example, analyte sensor system 308 can sampleblood glucose every 30 seconds, every 1 minute or according to any othersuitable periodic or aperiodic interval and generate raw analyte datafor the duration of a sensor session (e.g., a 1- or 10-day sensorsession, which can correspond to an intended user interval of theanalyte sensor system). In some embodiments, the raw analyte data cancomprise numerical indications of a voltage or current generated by ananalyte sensor, for example, sensor 375, as determined by, for example,sensor measurement circuitry 370.

Block 2804 includes storing the raw data. For example, analyte sensorsystem 308 can be configured to log the raw data generated by sensormeasurement circuitry 370, for example, in storage 365.

Block 2806 includes delaying conversion of the raw data to estimatedanalyte values until at least after the sensor session has concluded.For example, analyte sensor system 308 can be configured to not convertor otherwise process the raw data stored in storage 365 during thesensor session. In some embodiments, analyte sensor system 308 can beconfigured to convert and/or process the raw data after the sensorsession has concluded. Alternatively or additionally, analyte sensorsystem 308 can be configured to transmit the raw data and/or a processedversion of the raw data, processed by analyte sensor system 308 afterconclusion of the sensor session, to another device, e.g., HCP device150 (FIG. 26), server system 334 (FIG. 3A), or any other display devicedescribed herein, during or after the sensor session, for processing,analyzing and/or displaying after the sensor session has concluded.

Logging and Transfer of Analyte Data without a Display Device

In some embodiments, a user of an analyte sensor system, e.g., analytesensor system 308, may not have a smartphone, smartwatch or otherperipheral display device but can still want to be able to send theiranalyte concentration data to their health care provider. Accordingly,some embodiments of analyte sensor systems, as described herein, can befurther configured to communicate utilizing one or more cellularcommunication protocols, which can allow such analyte sensor systems topush data to a cloud, server or directly to a health care providerdevice, e.g., server system 334 and/or HCP device 150, without requiringany prior user pairing operation with the cloud, server, or HCP deviceand, in some cases, without necessarily providing visual indication ordisplay of the analyte concentration data to the patient or user of theanalyte sensor system. For example, transceiver 360 of any analytesensor system described herein can comprise a cellular network-enabledradio chip and/or transmitter. In some embodiments, the analyte sensorsystem can additionally or alternatively be configured to communicatethe analyte concentration data to the cloud, server or health careprovider device through a mesh network where enough intervening devicesbetween the analyte sensor system and the cloud, server or HCP deviceare available and appropriately configured.

Flowchart 2900 of FIG. 29 describes example operations of an analytesensor system, for example analyte sensor system 308 or any otheranalyte sensor system described herein, according to such cellularnetwork-enabled embodiments. Block 2902 includes measuring at least oneanalyte concentration value by an analyte sensor system during a sensorsession. For example, sensor 375 and/or sensor measurement circuitry 370of analyte sensor system 308 (or any other analyte sensor systemdescribed herein) can be configured to measure at least one analyteconcentration value (e.g., blood glucose) during a sensor session.

Block 2904 includes transmitting the at least one analyte concentrationvalue to a device associated with a health care provider utilizing acellular network connection. For example, transceiver 360 of analytesensor system 308 (or any other analyte sensor system described herein)can comprise a cellular network-enabled radio chip configured to pushdata to a cloud, server or directly to a health care provider device,e.g., server system 334 and/or HCP device 150. Such data transmissioncan occur without necessarily providing visual indication or display ofthe analyte concentration data to the patient or user of analyte sensorsystem 308.

Facilitating Troubleshooting of Customer Complaints

Use of analyte sensor systems, as those disclosed herein, can sometimesrequire technical trouble shooting. In some instances, a user cancontact customer support with a complaint relating to the analyte sensorsystem, for example, repeated connection losses, inability to connect,etc. While such complaints can be a result of a dead battery within theanalyte sensor system, customer support representatives can havelimited, if any, real-time information about the analyte sensor systemthat can be used to determine what, if any, issues actually exist.

Accordingly, the present disclosure contemplates embodiments in whichanalyte sensor systems can be configured with NFC circuitry that allowsan NFC communication from a separate display device to temporarilyprovide power to portions of the analyte sensor system necessary fortriggering and executing a download of data stored on the analyte sensorsystem, via another communication protocol, for example BLE, to thedisplay device for subsequent re-transmission to another server ordevice accessible to the customer service representative fortroubleshooting the customer complaint.

For example, as previously described, display device 310 (FIG. 3B) caninclude transceiver 320 comprising an NFC controller, as well ascircuitry configured for communicating according to at least two othercommunication protocols (e.g., BLE and Wi-Fi). Display device 310 canalso comprise storage 325 having stored thereon analyte sensorapplication 330, which in some cases can further include programming,code or instructions sufficient to direct a user, with or without theassistance of a customer service representative, to perform thetroubleshooting process described according to these embodiments.

Analyte sensor system 308 (FIG. 3B) can include transceiver 360comprising an NFC antenna and associated circuitry configured to receivepower, via NFC, from the NFC controller of transceiver 320 withindisplay device 310 when display device 310 is so instructed and broughtsufficiently close to analyte sensor system 308. Transceiver 360 can beconfigured to direct and/or otherwise use this received power to poweritself and any other elements within analyte sensor system 308 necessaryto communicate data stored in storage 365 to display device 310, forexample processor/microcontroller 380, real time clock 385 and/orstorage 365.

Upon receiving the power via NFC and powering up the necessary elements,analyte sensor system 308 can be configured to cause transceiver 360 totransmit data stored in storage 365 and/or data generated according toone or more operations of the troubleshooting procedure to displaydevice 310 utilizing a first communication protocol (e.g., BLE). Uponreceipt of the data from analyte sensor system 308, via the firstcommunication protocol, display device 310 can be configured toretransmit the data, utilizing a second communication protocol (e.g.,Wi-Fi) to another server or device accessible to the customer servicerepresentative, e.g., server system 334 (FIG. 3A). In such embodiments,the analyte sensor application 330 can be preloaded with an address orURL of the server or device to which the data is to be transmitted.

Once the customer service representative has access to the data, thecustomer service representative can utilize the data to determine orfacilitate a determination of an appropriate diagnosis, e.g., thetransmitter is bad, return to the manufacturer; there is a sensor issue,ask the user to try another sensor; the transmitter is out of usefullife, the warranty has expired and the transmitter worked appropriatelyfor the expected duration; or some other diagnosable condition.

In some embodiments, where this procedure is used in-factory foralready-returned analyte sensor systems, the process can be shortened byapplying NFC power to analyte sensor system 308, utilizing a factorydiagnostic tool having similar relevant functionality to display device310, and transferring the data from analyte sensor system 308 to thediagnostic tool via the first communication protocol (e.g., BLE). Such amethod could similarly be utilized for powering up malfunctioning orinoperable receivers or other dedicated display devices and initiating asimilar data transmission from the receiver or other dedicated displaydevice.

Description now turns to flowchart 3000 of FIG. 30A, describingoperations of, for example, analyte sensor system 308, as describedabove. Block 3002 includes receiving, by an analyte sensor system, powervia a near field communication from a first device and powering up atleast a portion of an analyte sensor system utilizing the receivedpower. For example, analyte sensor system 308 can be configured toreceive power via NFC, from display device 310, and to power up at leastsome of its elements for subsequent transmission of data.

Block 3004 includes transmitting data from the analyte sensor system tothe first device, utilizing a first communication protocol, for use introubleshooting a suspected malfunction of the analyte sensor system.For example, analyte sensor system 308 can be configured to causetransceiver 360 to transmit data stored in storage 365 and/or datagenerated according to one or more operations of the troubleshootingprocedure to display device 310 utilizing a first communication protocol(e.g., BLE).

Description now turns to flowchart 3050 of FIG. 30B, describingoperations of, for example, display device 310, as described above.Block 3052 includes disposing a display device sufficiently close to ananalyte sensor system for a short-term wireless communication protocolcontroller of the display device to transmit power, utilizing theshort-term wireless communication protocol, to the analyte sensorysystem, thereby powering up at least a portion of the analyte sensorsystem. For example, display device 310 can be disposed sufficientlyclose to analyte sensor system 308 for a near field communication (NFC)controller of transceiver 320 of display device 310 to transmit power,via NFC, to analyte sensory system 308, thereby powering up at least aportion of analyte sensor system 308.

Block 3054 includes receiving data from the analyte sensor system via afirst communication protocol. For example, upon transmitting the power,via NFC, display device 310 can receive data from analyte sensor system308 utilizing a first communication protocol (e.g., BLE).

Block 3056 includes re-transmitting the data to a second deviceaccessible to a customer service representative, via a secondcommunication protocol, for troubleshooting a suspected malfunction ofthe analyte sensor system. For example, upon receipt of the data fromanalyte sensor system 308, via the first communication protocol, displaydevice 310 can be configured to retransmit the data, utilizing a secondcommunication protocol (e.g., Wi-Fi) to another server or deviceaccessible to the customer service representative, e.g., server system334 (FIG. 3A).

Additional Embodiments

One of skill in the art will appreciate upon studying the presentdisclosure that various additional embodiments not described explicitlyherein are within the spirit and scope of the present disclosure.

FIG. 31 illustrates example computing module 3100, which can in someinstances include a processor/microprocessor/controller resident on acomputer system (e.g., in connection with server system 334, any of thedisplay devices described herein (e.g., display devices 120, 130, 140,310(a, b), as well as analyte display device 110, medical device 136,HCP device 150), and/or analyte sensor system 8, 308, etc.) Computingmodule 3100 can be used to implement various features and/orfunctionality of embodiments of the systems, devices, apparatuses, andmethods disclosed herein. With regard to the above-described embodimentsset forth herein in the context of systems, devices, apparatuses, andmethods described with reference to the various FIGS. of the presentdisclosure, one of skill in the art will appreciate additionalvariations and details regarding the functionality of these embodimentsthat can be carried out by computing module 3100. In this connection, itwill also be appreciated by one of skill in the art that features andaspects of the various embodiments (e.g., systems, devices, and/orapparatuses, and the like) described herein can be implemented withrespected to other embodiments (e.g., methods, processes, and/oroperations, and the like) described herein without departing from thespirit of the disclosure.

As used herein, the term module can describe a given unit offunctionality that can be performed in accordance with one or moreembodiments of the present application. As used herein, a module can beimplemented utilizing any form of hardware, software, or a combinationthereof. For example, one or more processors, controllers, ASICs, PLAs,PALs, CPLDs, FPGAs, logical components, software routines or othermechanisms can be implemented to make up a module. In implementation,the various modules described herein can be implemented as discretemodules or the functions and features described can be shared in part orin total among one or more modules. In other words, as would be apparentto one of ordinary skill in the art after reading this description, thevarious features and functionality described herein can be implementedin any given application and can be implemented in one or more separateor shared modules in various combinations and permutations. Even thoughvarious features or elements of functionality can be individuallydescribed or claimed as separate modules, one of ordinary skill in theart will understand that these features and functionality can be sharedamong one or more common software and hardware elements, and suchdescription shall not require or imply that separate hardware orsoftware components are used to implement such features orfunctionality.

Where components or modules of the application are implemented in wholeor in part using software, in one embodiment, these software elementscan be implemented to operate with a computing or processing modulecapable of carrying out the functionality described with respectthereto. One such example computing module is shown in FIG. 31. Variousembodiments are described in terms of example computing module 3100.After reading this description, it will become apparent to a personskilled in the relevant art how to implement the application using othercomputing modules or architectures.

Returning to FIG. 31, computing module 3100 can represent, for example,computing or processing capabilities found within mainframes,supercomputers, workstations or servers; desktop, laptop, notebook, ortablet computers; hand-held computing devices (tablets, PDA's,smartphones, cell phones, palmtops, etc.); other display devices,application-specific devices, or other electronic devices, and the like,depending on the application and/or environment for which computingmodule 3100 is specifically purposed.

Computing module 3100 can include, for example, one or more processors,microprocessors, controllers, control modules, or other processingdevices, such as a processor 3110, and such as can be included incircuitry 3105. Processor 3110 can be implemented using aspecial-purpose processing engine such as, for example, amicroprocessor, controller, or other control logic. In the illustratedexample, processor 3110 is connected to bus 3155 by way of circuitry3105, although any communication medium can be used to facilitateinteraction with other components of computing module 3100 or tocommunicate externally.

Computing module 3100 can also include one or more memory modules,simply referred to herein as main memory 3115. For example, randomaccess memory (RAM) or other dynamic memory can be used for storinginformation and instructions to be executed by processor 3110 orcircuitry 3105. Main memory 3115 can also be used for storing temporaryvariables or other intermediate information during execution ofinstructions to be executed by processor 3110 or circuitry 3105.Computing module 3100 can likewise include a read only memory (ROM) orother static storage device coupled to bus 3155 for storing staticinformation and instructions for processor 3110 or circuitry 3105.

Computing module 3100 can also include one or more various forms ofinformation storage devices 3120, which can include, for example, mediadrive 3130 and storage unit interface 3135. Media drive 3130 can includea drive or other mechanism to support fixed or removable storage media3125. For example, a hard disk drive, a floppy disk drive, a magnetictape drive, an optical disk drive, a CD or DVD drive (R or RW), or otherremovable or fixed media drive can be provided. Accordingly, removablestorage media 3125 can include, for example, a hard disk, a floppy disk,magnetic tape, cartridge, optical disk, a CD or DVD, or other fixed orremovable medium that is read by, written to or accessed by media drive3130. As these examples illustrate, removable storage media 3125 caninclude a computer usable storage medium having stored therein computersoftware or data.

In alternative embodiments, information storage devices 3120 can includeother similar instrumentalities for allowing computer programs or otherinstructions or data to be loaded into computing module 3100. Suchinstrumentalities can include, for example, fixed or removable storageunit 3140 and storage unit interface 3135. Examples of such removablestorage units 3140 and storage unit interfaces 3135 can include aprogram cartridge and cartridge interface, a removable memory (forexample, a flash memory or other removable memory module) and memoryslot, a PCMCIA slot and card, and other fixed or removable storage units3140 and storage unit interfaces 3135 that allow software and data to betransferred from removable storage unit 3140 to computing module 3100.

Computing module 3100 can also include a communications interface 3150.Communications interface 3150 can be used to allow software and data tobe transferred between computing module 3100 and external devices.Examples of communications interface 3150 include a modem or softmodem,a network interface (such as an Ethernet, network interface card,WiMedia, IEEE 802.XX or other interface), a communications port (such asfor example, a USB port, IR port, RS232 port Bluetooth® interface, orother port), or other communications interface configured to operationwith the communication media described herein. Software and datatransferred via communications interface 3150 can typically be carriedon signals, which can be electronic, electromagnetic (which includesoptical) or other signals capable of being exchanged by a givencommunications interface 3150. These signals can be provided to/fromcommunications interface 3150 via channel 3145. Channel 3145 can carrysignals and can be implemented using a wired or wireless communicationmedium. Some non-limiting examples of channel 3145 include a phone line,a cellular or other radio link, an RF link, an optical link, a networkinterface, a local or wide area network, and other wired or wirelesscommunications channels.

In this document, the terms “computer program medium” and “computerusable medium” and “computer readable medium”, as well as variationsthereof, are used to generally refer to transitory or non-transitorymedia such as, for example, main memory 3115, storage unit interface3135, removable storage media 3125, and/or channel 3145. These and othervarious forms of computer program media or computer usable/readablemedia can be involved in carrying one or more sequences of one or moreinstructions to a processing device for execution. Such instructionsembodied on the medium, can generally be referred to as “computerprogram code” or a “computer program product” or “instructions” (whichcan be grouped in the form of computer programs or other groupings).When executed, such instructions can enable the computing module 3100,circuitry related thereto, and/or a processor thereof or connectedthereto to perform features or functions of the present disclosure asdiscussed herein (for example, in connection with methods describedabove and/or in the claims), including for example when the same is/areincorporated into a system, apparatus, device and/or the like.

Various embodiments have been described with reference to specificexample features thereof. It will, however, be evident that variousmodifications and changes can be made thereto without departing from thebroader spirit and scope of the various embodiments as set forth in theappended claims. The specification and figures are, accordingly, to beregarded in an illustrative rather than a restrictive sense.

Although described above in terms of various example embodiments andimplementations, it should be understood that the various features,aspects and functionality described in one or more of the individualembodiments are not limited in their applicability to the particularembodiment with which they are described, but instead can be applied,alone or in various combinations, to one or more of the otherembodiments of the present application, whether or not such embodimentsare described and whether or not such features are presented as being apart of a described embodiment. Thus, the breadth and scope of thepresent application should not be limited by any of the above-describedexample embodiments.

Terms and phrases used in the present application, and variationsthereof, unless otherwise expressly stated, should be construed as openended as opposed to limiting. As examples of the foregoing: the term“including” should be read as meaning “including, without limitation” orthe like; the term “example” is used to provide illustrative instancesof the item in discussion, not an exhaustive or limiting list thereof;the terms “a” or “an” should be read as meaning “at least one,” “one ormore” or the like; and adjectives such as “conventional,” “traditional,”“normal,” “standard,” “known” and terms of similar meaning should not beconstrued as limiting the item described to a given time period or to anitem available as of a given time, but instead should be read toencompass conventional, traditional, normal, or standard technologiesthat may be available or known now or at any time in the future.Similarly, the plural can in some cases be recognized as applicable tothe singular and vice versa. Likewise, where this document refers totechnologies that would be apparent or known to one of ordinary skill inthe art, such technologies encompass those apparent or known to theskilled artisan now or at any time in the future.

The presence of broadening words and phrases such as “one or more,” “atleast,” “but not limited to” or other like phrases in some instancesshall not be read to mean that the narrower case is intended or requiredin instances where such broadening phrases can be absent. The use of theterm “module” does not imply that the components or functionalitydescribed or claimed as part of the module are all configured in acommon package. Indeed, any or all of the various components of amodule, whether control logic, circuitry, or other components, can becombined in a single package or separately maintained and can further bedistributed in multiple groupings or packages or across multiplelocations.

Additionally, the various embodiments set forth herein are described interms of example block diagrams, flow charts, and other illustrations.As will become apparent to one of ordinary skill in the art afterreading this document, the illustrated embodiments and their variousalternatives can be implemented without confinement to the illustratedexamples. For example, block diagrams and their accompanying descriptionshould not be construed as mandating a particular architecture orconfiguration. Moreover, the operations and sub-operations of variousmethods described herein are not necessarily limited to the orderdescribed or shown in the figures, and one of skill in the art willappreciate, upon studying the present disclosure, variations of theorder of the operations described herein that are within the spirit andscope of the disclosure.

In addition, the operations and sub-operations of methods describedherein can be carried out or implemented, in some cases, by one or moreof the components, elements, devices, modules, circuitry, processors,etc. of systems, apparatuses, devices, environments, and/or computingmodules described herein and referenced in various of FIGS. of thepresent disclosure, as well as one or more sub-components, elements,devices, modules, processors, circuitry, and the like depicted thereinand/or described with respect thereto. In such instances, thedescription of the methods or aspects thereof can refer to acorresponding component, element, etc., but regardless of whether anexplicit reference is made, one of skill in the art will recognize uponstudying the present disclosure when the corresponding component,element, etc. can be used. Further, it will be appreciated that suchreferences do not necessarily limit the described methods to theparticular component, element, etc. referred to. Thus, it will beappreciated by one of skill in the art that aspects and featuresdescribed above in connection with (sub-) components, elements, devices,modules, and circuitry, etc., including variations thereof, can beapplied to the various operations described in connection with methodsdescribed herein, and vice versa, without departing from the scope ofthe present disclosure.

What is claimed is:
 1. A method for wireless communication of continuousanalyte concentration data, the method comprising: transmitting one ormore first advertising messages utilizing a first set of parametersduring a predetermined communication interval if a whitelist ofpreviously authenticated devices has at least one unfilled entry;transmitting one or more second advertising messages utilizing a secondset of parameters during the predetermined communication interval if thewhitelist lists at least one device; establishing a first communicationsession between an analyte sensor system and a first device and a secondcommunication session between the analyte sensor system and a seconddevice during the predetermined communication interval based on at leastone of the first advertising messages and the second advertisingmessages; and transmitting analyte concentration data to the firstdevice and to the second device utilizing at least one of the firstcommunication session and the second communication session during thepredetermined communication interval.
 2. The method of claim 1, wherein:the one or more first advertising messages advertise availability of theanalyte sensor system for connection with one or more devices that arenot currently listed on the whitelist; and the one or more secondadvertising messages advertise availability of the analyte sensor systemfor connection with one or more devices currently listed on thewhitelist.
 3. The method of claim 1, wherein the one or more firstadvertising messages are transmitted after the one or more secondadvertising messages.
 4. The method of claim 1, wherein the one or morefirst advertising messages are transmitted before the one or more secondadvertising messages.
 5. The method of claim 1, further comprising nottransmitting the one or more first advertising messages during thepredetermined communication interval if the whitelist does not have atleast one unfilled entry.
 6. The method of claim 1, further comprisingnot transmitting the one or more second advertising messages during thepredetermined communication interval if the whitelist does not currentlylist any devices.
 7. The method of claim 1, further comprising nottransmitting the one or more second advertising messages during thepredetermined communication interval if all devices currently listed onthe whitelist connected to the analyte sensor system responsive to theone or more first advertising messages.
 8. The method of claim 1,wherein the first set of parameters define one or more of: a firstduration of a first advertising interval for transmitting the one ormore first advertising messages; a first periodic interval fortransmission of the one or more first advertising messages; and a firstpower for transmission of the one or more first advertising messages. 9.The method of claim 8, wherein the second set of parameters define oneor more of: a second duration of a second advertising interval fortransmitting the one or more second advertising messages; a secondperiodic interval for transmission of the one or more second advertisingmessages; and a second power for transmission of the one or more secondadvertising messages.
 10. The method of claim 9, wherein the first powerfor transmission of the one or more first advertising messages is lowerthan the second power for transmission of the one or more secondadvertising messages.
 11. The method of claim 1, wherein devicesutilized by consumers and devices utilized by medical professionals areboth eligible for inclusion in the whitelist.
 12. The method of claim 1,wherein the whitelist comprises 3 or more entries.
 13. A continuousanalyte sensor system configured for wireless communication of analyteconcentration data, comprising: a transceiver radio configured to:transmit one or more first advertising messages utilizing a first set ofparameters during a predetermined communication interval if a whitelistof previously authenticated devices has at least one unfilled entry; andtransmit one or more second advertising messages utilizing a second setof parameters during the predetermined communication interval if thewhitelist lists at least one device; one or more processors configuredto: establish a first communication session between the analyte sensorsystem and a first device and a second communication session between theanalyte sensor system and a second device based on at least one of thefirst advertising messages and the second advertising messages; andcausing the transceiver radio to transmit analyte concentration data tothe first device and to the second device utilizing at least one of thefirst communication session and the second communication session duringthe predetermined communication interval.
 14. The analyte sensor systemof claim 13, wherein the one or more processors are configured to causethe transceiver radio to not transmit the one or more first advertisingmessages during the predetermined communication interval if thewhitelist does not have at least one unfilled entry.
 15. The analytesensor system of claim 13, wherein the one or more processors areconfigured to cause the transceiver radio to not transmit the one ormore second advertising messages during the predetermined communicationinterval if the whitelist does not currently list any devices.
 16. Theanalyte sensor system of claim 13, wherein the one or more processorsare configured to cause the transceiver radio to not transmit the one ormore second advertising messages during the predetermined communicationinterval if all devices currently listed on the whitelist connected tothe analyte sensor system responsive to the one or more firstadvertising messages.
 17. A continuous analyte sensor system,comprising: a transceiver radio configured to: establish a firstcommunication session with a first display device and a secondcommunication session with a second display device; and transmit analytesensor data to the first display device via the first communicationsession; a storage configured to store the analyte sensor data at leastduring a time period, subsequent to establishing the secondcommunication session, during which the second display device becomesunavailable for communication with the first device and with the analytesensor system; and one or more processor configured to cause thetransceiver radio to transmit the stored analyte sensor data to thesecond display device utilizing the second communication sessionresponsive to the second display device becoming available forcommunication with the analyte sensor system after the time period.